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Category

Malformation Embolisation

PHIL AVF

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Objectives

Safety evaluation at 1 month after each embolization, 3-6 months after last embolization and efficacy 3-6 months after the last embolization treatment of dAVF with PHIL used with or without other embolization products (cyanoacrylate glue, coils, balloon, etc.).

71

Number of Patients

France (4)

Spain (4)

United Kingdom (2)

Sweden (2)

Denmark (1)

Design

Single arm prospective

Scope

All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL used with or without other embolization products .

Endpoints

Efficacy results

Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated) at 3-6 months after last embolization compared to baseline
Cure rate assessment by Angiography

Safety results

Number of adverse events and assessment of neurological status at 1 month after each embolization compared to baseline

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03317821

SPONSOR Microvention-Terumo, Inc.

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PHIL cAVM

PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)

Objectives

Assess efficacy and safety of PHIL® in endovascular embolization of cAVM.
Evaluate cure rate and safety outcome of cAVM treatment with PHIL based on initial treatment strategy.
Follow-up at 1Mo after each embolization session then at 3-6Mo post last embolization session.
Study set up to get reimbursement in France

20

Number of Patients

France (4)

Spain (4)

United Kingdom (2)

Sweden (1)

Denmark (1)

Design

Single arm prospective

Scope

All patients with a cAVM, ruptured or unruptured, eligible for EVT with PHIL, based on multidisciplinary consensus.

Endpoints

Efficacy results

Cure rate of cAVM with PHIL immediately after last embolization in all patients

Cure rate at 3-6 months in patients treated with EVT alone

Safety results

Clinical outcome compared to baseline by mRS at discharge, 1 month after each procedure and at 3-6 months after the final embolization in all patients performed by an independent neurologist.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03341039

SPONSOR Microvention-Terumo, Inc.

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Category

Aneurysm Intravascular Treatment

LVIS Pivotal study

Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support) (LVIS)

Objectives

The pivotal US LVIS study is an IDE study designed to determine the safety and effectiveness of the LVIS device-supported coil embolization of WNAs located in the anterior and posterior intracranial circulations. Data from this study were used to support a US regulatory submission for premarket approval.

153

Number of Patients

United States (21)

Design

Single arm prospective

Scope

“Patient between 18-75y.o., with unruptured or ruptured (>30days) wide neck, saccular,intracranial aneurysm, ≥ 4mm and < 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio < 2).
Subject’s aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.”

Endpoints

Effectiveness Composite Success Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment) at 12 months
Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months

Efficacy results

Complete (100%) aneurysm occlusion and <50% stenosis of the treated artery at 12Mo by angiography evaluated by Corelab: 70.6%

Safety results

Rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12Mo: 5.2%

Study Publications

Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK; LVIS investigators. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. J Neurointerv Surg. 2019 Apr;11(4):357-361. doi: 10.1136/neurintsurg-2018-014309. Epub 2018 Oct 8.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01793792

SPONSOR Microvention-Terumo, Inc.

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LVIS Feasibility Study

Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device (LVIS)

Objectives

The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.

30

Number of Patients

United States (6)

Design

Single arm prospective

Scope

Patient between 18-80y.o., with unruptured wide neck, saccular,intracranial aneurysm, < 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio < 2).
Subject’s aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.

Endpoints

Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)
Imaging to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months

Study Publications

Fiorella D, Arthur A, et al. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01541254

SPONSOR Microvention-Terumo, Inc.

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FRED US pivotal trial

Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms (FRED)

Objectives

To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.

145

Number of Patients

United States (23)

Japan (1)

Design

Single arm prospective

Scope

Patients aged 22-75y.o., single target aneurysm located in the ICA,

Endpoints

Complete Occlusion with stenosis ≤50% and no retreatment within 12 months

Neurological Death or Major Ipsilateral Stroke at 12 months
Major stroke is defined as a new neurological event that persists for > 24 hours and results in a ≥ 4 points increase in the NIHSS score compared to baseline.
Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.

Efficacy results

Effectiveness achieved with PG of >46% aneurysm occlusion
Effectiveness endpoint was met in 80/139 (57.6%)

Safety results

Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant.
Safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%.

Study Publications

McDougall CG, Diaz O. et al. Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial. Neurintsurg-2021-017469

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01801007

SPONSOR Microvention-Terumo, Inc.

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FRED UK

Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment

Objectives

To demonstrate that use of the FRED/FRED Jr Embolic device in intracranil AN treatment is safe and effective when assessed at 1, 6 and 12 month post procedure.

61

Number of Patients

United Kingdom (7)

Design

Single arm prospective

Scope

Patients ≥18 y.o. presenting with an unruptured or recanalized IC aneurysm, from anterior circulation, requiring endovascular treatment, mRS≤2, eligible to be treated with FRED/FRED Jr.

Endpoints

Complete aneurysm occlusion without ˃ 50% parent artery stenosis at 6 months, evaluated by Corelab
Morbidity rate at 6 months, patients with mRS>2
Mortality rate at 6 months, patients with mRS=6

Efficacy results

At 6 months : rate of complete occlusion without associated stenosis of parent artey (>50%) = 63.3%

Adequate occlusion (12 months) = 86.4%”

Safety results

Morbidity (mRS<2) =0%
Mortality = 0%”

Study Publications

Article in preparation

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03423290

SPONSOR Microvention-Terumo, Inc.

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LEPI

Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms

Objectives

Post reimbursement study evaluating morbi-mortality post procedure and at 1 year defined as AE with clinical sequelae and related to the device or the procedure

130

Number of Patients

France (20)

Design

Single arm prospective

Scope

All patients with aneurysms treated with LVIS/LVIS Jr in France

Endpoints

Mortality Rate at 1 year
Morbidity Rate at 1 year : Number of adverse events with clinical impact related to the procedure and/or the device

Efficacy results

All aneurysms (134/134, 100%) were successfully treated with LVIS stent and/or other devices. At a mean FU of 16.8 months post-procedure, complete/nearly complete occlusion was achieved in 112 aneurysms (92.6%), and only 3 patients (2.5%) required aneurysm retreatment.

Safety results

The cumulative morbidity and mortality rate (CMMR) at 1 year related to the procedure and/or device was 4.6% (6/130).
The overall mortality was 1.5% (2/130), none of these deaths adjudged as being linked to the procedure and/or device.

Study Publications

Forestier G. et al. Safety And Effectiveness Of The LVIS And LVIS Jr Devices For The Treatment Of Intracranial Aneurysms: Final Results Of The LEPI Multicenter Cohort Study. J Neuroradiol. 2023 Oct 17:S0150-9861(23)00253-5

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03553771

SPONSOR Microvention-Terumo, Inc.

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TRAIL

TRAIL: Treatment of Intracranial Aneurysms With LVIS® System (TRAIL)

Objectives

Assessment of safety and efficacy at 12-18Mo to obtain reimbursement in France

90

Number of Patients

France (9)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o. presenting with unruptured or ruptured, aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is < 2, WFNS (between 0 and 3), eligible to be treated with LVIS/LVIS Jr

Endpoints

“• Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm at 6 and 18 months
• Retreatment rate at 6 and 18 months
• Morbidity rate at 6 and 18 months
• Mortality rate at 6 and 18 months”

Efficacy results

At 6Mo:

100% stent stability
No parent artery stenosis: 100%
Complete occluion: 91%

At 18Mo:

100% stent stability
No parent artery stenosis: 100%
Complete occluion: 92.4 %
Retreatment: 2%

Safety results

At 6Mo:

Morbidity (mRS>2): 4.4%
Mortality: 2.2%-

At 18Mo:

Morbidity (mRS>2): 5.6%
Mortality: 5.6%- 2/5 device/procedure related

Study Publications

Iosif C, Piotin M, Saleme S, et al. Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study. J NeuroIntervent Surg, 2018

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02921711

SPONSOR Microvention-Terumo, Inc.

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SAFE

Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment (SAFE)

Objectives

Assessment of safety and efficacy at 12-18Mo to obtain reimbursement in France

103

Number of Patients

France (13)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o. presenting with one unruptured or recanalized IC aneurysm, non acutely ruptured, from anterior circulation, requiring EVT, mRS≤2, eligible to be treated with FRED/FRED Jr

Endpoints

Aneurysm occlusion without ˃ 50% parent artery stenosis at 6 months
Morbidity rate at 6 months
Mortality rate at 6 months

Efficacy results

At 6Mo:

Complete occlusion without parent artery stenosis: 55.3%
Complete occluion: 61%

At 12Mo:

Complete occlusion without parent artery stenosis: 66.7%
Complete occluion: 73.3 %

Safety results

At 6Mo:

Morbidity (mRS>2): 2%
Mortality: 1%

At 12Mo:

Morbidity (mRS>2): 2.9%- 1 intraoperative TE, 1 Long term TE, 1 delayed AN ruptur
Mortality: 1.9%

Study Publications

Pierot, L., Spelle, L., Berge, J., et al. Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE Study. J NeuorIntervent Surg, 2018

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02921698

SPONSOR Microvention-Terumo, Inc.

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FRED Poland

Observational Study for Evaluation of the Safety and Performance of the MicroVention Flow Redirection Intraluminal Device (FRED Stent system) for the Treatment of Selected Intracranial

Objectives

Evaluation of the safety of the FRED throughout the complete follow-up period of 24 months and effectiveness of the FRED in the treatment of selected types of intracranial aneurysms in selected locations assessed at the 6- and 12-months follow-ups

86

Number of Patients

Poland (8)

Design

Single arm prospective

Scope

Patients with unruptured aneurysms from ICA segment C2-C6 or above PICA,

Endpoints

Primary effectiveness endpoint: percentage of aneurysms with successful isolation from the rest of the circulation and patency of FDV lumen at 6 and 12 months follow-up. The isolation will be classified in five possible levels by the imaging corelab.
Primary safety endpoint: rate of clinical complications (number of complications / number of stents implanted) after stent deployment classified by the Central Event Committee (CEC) as:
- early thromboembolic complications (during the first 3 months);
- late thromboembolic complications (between 3 and 24 months);
- haemorrhage from the treated aneurysm.”

Efficacy results

At 6Mo:

Complete occlusion without parent artery stenosis: 61.8%
Complete occluion: 64.9%

At 12Mo:

Complete occlusion without parent artery stenosis: 76.1%
Complete occluion: 79.5 %

At 24Mo:

Complete occlusion without parent artery stenosis: 82.5%
Complete occluion: 85.5 %

Safety results

Primary safety endpoint (Rate of clinical complications classified by the CEC as early thromboembolic complication, late thromboembolic complication or hemorrhage from the treated aneurysm) = 10.%
Rate of neurological permanent morbidity and mortality = 6.0%
All-cause mortality rate = 3.6%”

Study Publications

Results will be pooled in the FRED Meta-analysis

LINK TO STUDY PAGE

SPONSOR MVE

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Category

Aneurysm Embolisation

CLEVER

CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms (CLEVER)

Objectives

To assess clinical utility of WEB 17. Efficacy:Adequate occlusion at 12Mo
Safety: rate of death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.

163

Number of Patients

Germany (7)

France (6)

Finland (2)

United Kingdom (1)

Hungary (1)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o., but ≤ 80 y.o. requiring treatment for ruptured or unruptured IC aneurysms with WEB 0.017 only.

Endpoints

Aneurysm occlusion at 12 months
Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC)
Incidence of major stroke or neurological deaths at 12months :
The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment

Safety results

* At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%)

* Overall morbidity rates :
– at 1 month = 9/159 (5.7%)
– 1 year = 3/151 (2.0%)

* Overall mortality rates :
– at 1 month = 0%
– 1 year = 1/154 (0.6%) – No device-related mortality

Study Publications

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms – J Neurointerv Surg. 2023 Nov 1:jnis-2023-020866. doi: 10.1136/jnis-2023-020866

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03844334

SPONSOR Microvention-Terumo, Inc.

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CLARYS

CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms (CLARYS)

Objectives

An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.

60

Number of Patients

France (1)

Design

Single arm prospective

Scope

Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms.
Intervention: Device: WEB Aneurysm Embolization System

Endpoints

Re-Bleed rate after treatment during the period extending from post-procedure up to 1 month. Definitions:

Re-bleeding from target aneurysm is defined as patent evidence of hemorrhage on CT or MRI AND hemorrhage is depicted in the same territory as the initial bleeding AND hemorrhage has increased in size compare to initial pre-operative CT
Screening for re-bleeding: During hospital stay of the patient and up to 1-month, any worsening of the clinical status should lead to perform a non-enhanced CT or MRI.

Or, as per-center standard care, non-enhanced CT or MRI might be performed systematically during hospital course.”

Study Publications

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study – Spelle L, et al. J NeuroIntervent Surg 2021;0:1–8. doi:10.1136/neurintsurg-2021-017416

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02687607

SPONSOR Microvention-Terumo, Inc.

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GREAT

Randomized controlled multicentre study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment

Objectives

To compare HydroSoft (including Hydroframe) versus bare platinum coils

484

Number of Patients

France

Germany (22)

Design

RCT

Scope

Patients aged 18-75 years presenting a cerebral aneurysm ruptured or unruptured
WFNS Grade 0-3
Aneurysm 4-12 mm in diameter

Endpoints

Primary outcome: Composite outcome of major aneurysm recurrence on follow-up angiography and clinical outcome within 18 months.
Secondary outcomes:
– Packing density
– Coil length deployed
– Clinical outcome at 6 and 18 months post-coiling, as measured by the modified Rankin scale”

Efficacy results

Unfavorable Composite (recurrence , retreatment,Morbidity) = 19,9% (HES) / 28,7% (BPC)
Complete occlusion at 18 Mo = 69% (HES) vs 53% (BPC)
Major recurrence = 12% (HES) vs 18% (BPC)
Retreatment rate = 3% (HES) vs 6% (BPC)”

Safety results

Procedural complications = 12.7% (HES) vs 12.4% (BPC)
The 14-day mortality rate = 2.0% (HES) vs 2.1% (BPC)
At 18 Mo: mRS 3-5 = 3% (HES) vs 1% (BPC)
mRS 6 = 3% (HES) vs 4% (BPC)
* Rupt. An. mRS 3-5 = 5% (HES) vs 2% (BPC)
mRS 6 = 5% (HES) vs 7% (BPC)
* Unrupt. An. mRS 3-5 = 1% (HES) vs 1% (BPC)
mRS 6 = 1% (HES) vs 2% (BPC)

Study Publications

Taschner C, Chapot R, Costalat V, et al. GREAT-a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment. Neuroradiology 2015;57:599-604.

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SPONSOR Freiburg Hospital Germany

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COAST

COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils (COAST)

Objectives

To demonstrate that interventional treatment of small aneurysms using current coiling technology is safe and effective.

300

Number of Patients

United States (15)

Design

Single arm prospective

Scope

Patients w/small (≤ 4.9mm) aneurysms treated w/HyperSoft®/HyperSoft® 3D (Phase I) or HydroFrame®/HydroSoft® 3D (Phase II).

Endpoints

“Imaging outcomes (occlusion results) of small intracranial aneurysms as defined by the raymond Roy Grading scale at 48 hours :
To measure imaging outcomes of small (≤ 4.9 mm) intracranial aneurysms utilizing the HyperSoft® 3D (and HydroSoft® 3D, when commercially available) and HyperSoft® helical coils specifically designed for the treatment of small aneurysms.”

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02259504

SPONSOR Medical University of South Carolina

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HELPS

HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial)

Objectives

Compare safety and efficacy of HydroCoil vs platinum.

499

Number of Patients

United States

United Kingdom

Brazil

Germany

Australia

Argentina

France (24)

Design

RCT

Scope

Patients 18-75, ruptured or unruptured, 2-25mm. Hydrogel arm targeted to have > 50% packing w/gel or > 50% gel length deployed.

Endpoints

“Primary outcome: major aneurysm recurrence (Recurrence defined as adequate space in the aneurysm to deploy further coils)
Secondary outcomes: clinical outcome, rebleed, and retreatment rates”

Efficacy results

Adverse primary outcome: 28% HES vs 36% BPC (adverse outcome includes major recurrence and morbidity/mortality preventing angiographic f/u)
Major recurrence: 24% HES vs 33% BPC

Safety results

mRS ≥ 3 at 18 mo: 15.7% HES vs 12.8% BPC

Study Publications

White PM, Lewis SC, Nahser H, et al. HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results. AJNR Am J Neuroradiol 2008;29:217-223.

LINK TO STUDY PAGE

SPONSOR Microvention-Terumo, Inc.

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Gel-the-nec

Registry for Study of Coils in Intracranial Aneurysms (Gel-the-nec)

Objectives

Assess safety and efficacy of trearting aneurysms with HES coils used as finishing coils

599

Number of Patients

United States

United Kingdom

China

Korea

Japan (27)

Design

Single arm prospective

Scope

patients>20y.o.<91y.o., ruptured or unruptured AN 3-15mm, HydroSoft required as first attempt for all coils ≤ 3mm

Endpoints

We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils at 6 – 18 months post coiling

Efficacy results

Adequate occlusion: 88.4%
Recanalization: 10.8%
Retreat: 3.4%

Safety results

Procedure-related mortality: 0.5%
Procedure-related morbidity: 1.3%

Study Publications

Brinjikji W, Amar A, Almandoz J et al. GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device. J Neurointerv Surg 2017: Published online first January 10th, 2017 (Available on Seismic)

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01000675

SPONSOR Mayo Clinic

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HEAT

Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

Objectives

Compare recurrence between second generation of HES and bare platinum coils. Recurrence defined as any progression on Raymond Roy scale.

600

Number of Patients

United States (46)

Design

RCT

Scope

patients>18y.o.<75y.o., ruptured or unruptured AN 3-14mm, H&H<4

Endpoints

Number of Patients with Aneurysm Recurrence Post Surgery to 24 months
Defined as any progression on the Raymond-Roy (RR) Aneurysm Occlusion Scale.

Efficacy results

Aneurysm recurrence: 4.4% HES vs 15.4% BPC
Major recurrence (from R1 to R3, R2 to R3, R3): 12,8% vs 20,7%
Minor recurrence (from R1 to R2): 1% HES vs 5% BPC
Packing density: 32,5% HES vs 24,7% BPC (p<.001)
Initial complete occlusion: 17,8% HES vs 28,3% BPC
BUT at 3-12Mo: 64,9% HES vs 49% BPC
at 18-24Mo: 68,6% HES vs 51,5% BPC
Retreat: 5.2% HES vs 8.3% BPC

Safety results

AE related to procedure/device: 21.6% HES vs 24.8% BPC
Mortality: 2.4% HES vs 3.0% BPC
Device- or procedure-related hemorrhage: 1.7% vs 1.3%”

Study Publications

Abi-Aad K, Aoun R, Rahme R, et al. New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial. Neuroradiology, 2018.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01407952

SPONSOR Northwestern University

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WEB French Observatory

WEB French Observatory of the WEB Aneurysm Embolization System

Objectives

Assessment of safety and efficacy at 1 year

61

Number of Patients

France (10)

Design

Single arm prospective

Scope

patients>18y.o.<75y.o., ruptured or unruptured AN, H&H<3

Endpoints

Efficacy :

Durability of aneurysm occlusion at 12 months
Durability of occlusion compared to post-procedure imaging

Efficacy results

At 12 Mo :

Complete occlusion: 51.7% / Adequate occlusion: 79.3%

Safety results

At 30 days:

Morbidity: 3.2%
Mortality: 0%

At 12 Mo:

Morbidity: 0%
Mortality:3.4%

Study Publications

Pierot L, et al.; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01975233

SPONSOR Microvention-Terumo, Inc.

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WEBCAST

Extension of WEBCAST study

Objectives

Assessment of efficacy, technical success, and safety up to 5 years

55

Number of Patients

France (5)

Hungary (1)

Germany (2)

Belgique (1)

Denmark (1)

Design

Single arm prospective

Scope

patients>18y.o.<75y.o., ruptured or unruptured AN, H&H<3

Endpoints

Durability of occlusion at 6 months

Efficacy results

At 6 Mo :

Complete occlusion: 57.1% / Adequate occlusion: 79.6%

At 12 Mo :

Complete occlusion: 54.0% / Adequate occlusion: 80.0%”

Safety results

At 30 days:

Morbidity: 3.6%
Mortality:0%

At 6 Mo and 12 Mo:

Morbidity: 3.9%
Mortality:2%”

Study Publications

Pierot L, et al. Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST 2 study. J Neurorad 2016;124:1250–6.

Pierot L, et al. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368

LINK TO STUDY PAGE

SPONSOR Microvention-Terumo, Inc.

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WEBCAST

WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST)

Objectives

Assessment of safety and efficacy up to 5 years.

50

Number of Patients

France (5)

Hungary (1)

Germany (2)

Belgique (1)

Denmark (1)

Design

Single arm prospective

Scope

Patients>18y.o.<75y.o., with intracranial aneurysms

Endpoints

Durability of occlusion at 6 months

Efficacy results

At 6 Mo:

Primary endpoiint- Success:
Complete occlusion or stable neck remnant with no worsening from baseline and no retreatment performed or planned
– Rate of success : 79.6%
– Adequate occlusion: 85.4%

Safety results

At 30 days:

Morbidity: 2.0%
Mortality:0%

At 6 Mo:

Morbidity: 0%
Mortality:4.17%

Morbidity:

mRS > 2 if baseline ≤ 2
mRS +1 or more if baseline >2
mRS >2 and ruptured at baseline

Study Publications

Pierot L, et al.; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01778322

SPONSOR Microvention-Terumo, Inc.

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Category

Mechanical Thrombectomy

BOBBY STUDIE TEST

Objectives

10

Number of Patients

Design

Scope

Endpoints

LINK TO STUDY PAGE

SPONSOR Microvention-Terumo, Inc.

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STABILISE

Stroke: an evaluation of thrombectomy in the ageing brain version 1 (STABILISE)

Objectives

“This study will investigate whether treatment using a purpose designed new clot retrieval device is at least as safe and effective in unblocking the occluded blood vessel after an acute ischaemic stroke as existing devices. The new device has design features that may be particularly useful in elderly patients with more difficult vascular access.
This study will investigate whether additional brain imaging would be helpful in acute stroke patients treated with clot retrieval by:
1. Examining whether analysis of blood vessels on the scans taken before treatment starts can predict who will or will not do well, and see if there is any link to age.
2. Detailed MRI brain scan 24h after treatment to see if scan findings at that stage can predict long term outcome, identify complications not appreciated on routine CT and see whether these are linked to patient age.”

66

Number of Patients

United Kingdom

Design

RCT

Scope

Endpoints

Feasibility and technical efficacy and safety of two novel thrombectomy devices – ERIC (a retriever device) and SOFIA (a distal access catheter) – used alone or in combination depending on operator preference.

Study Publications

Evaluation of stroke thrombectomy including patients where IV thrombolysis is contraindicated or has failed: a randomized trial of two novel thrombectomy devices – White PM, et al. J NeuroIntervent Surg 2021;13:311–317. doi:10.1136/neurintsurg-2020-016038

LINK TO STUDY PAGE

ClinicalTrials.gov number ISRCTN15698516

SPONSOR Biomedical Research Centre (UK)

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ERASER

ERic Acute StrokE Recanalization (ERASER)

Objectives

To monitor the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on artery recanalization and on clinical outcomes in stroke patients using data from clinical routine application (ERASER).
To additionally evaluate the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on the final infarct volume as determined by advanced image postprocessing methods in the subgroup of patients with acute middle cerebral artery stroke (ERASER+).”

53

Number of Patients

Germany (8)

Switzerland (1)

Design

Single arm prospective

Scope

Patients over 18 year with acute ischemic stroke with NIH-SS score of 8-25, Intended usage of ERIC® as first device in combination with SOFIA™ Distal Access -Catheter (secondary bail-out with other devices allowed)

Endpoints

VOST (volume of saved tissue) = VPIv- VMT at 30 h :
volume of saved tissue (VOST) as difference of the brain volume with an infarct risk of >50%, based on a prediction- algorithm trained in a historical cohort treated with IV tPA (VPIv) and the actual infarct volume

Study Publications

ERASER A Thrombectomy Study With Predictive Analytics End Point – Fiehler J, Thomalla G, Bernhardt M, Kniep H, Berlis A, Dorn F, Eckert B, Kemmling A, Langner S, Remonda L, Reith W, Rohde S, Mohlenbruch M, Bendszus M, Forkert ND, Gellissen S. ERASER. Stroke. 2019 May;50(5):1275-1278. doi: 10.1161/STROKEAHA.119.024858.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02534701

SPONSOR Heidelberg Hospital - Universitätsklinikum Hamburg-Eppendorf

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SESAME

Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke (SESAME)

Objectives

To demonstrate that use of SOFIA/SOFIA PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment.

250

Number of Patients

France (6)

Germany (5)

Austria (2)

Italy (1)

Netherlands (2)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o. presenting with an acute stroke in the anterior cerebral circulation that can be treated within 6 hrs from AIS symptom onset. Those eligible to be treated with SOFIA/ SOFIA PLUS will be enrolled after having signed an informed consent form (or having one signed on his or her behalf by a legally authorized representative or an independent physician).

Endpoints

Clinical outcome at 90 days :
Dichotomization of patients into good functional outcome defined as a modified Rankin Score (mRS) ≤ 2 and bad functional outcome defined as mRS >2

Study Publications

Study analysis in process

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03417349

SPONSOR Heidelberg Hospital - Dr. Markus Alfred Möhlenbruch

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Malformation Embolisation

PHIL^TM
Liquid Embolic System

PHIL AVF

PHIL Evaluation in the Endovascular Treatment of Intracranial Dural AVF

Objectives

Safety evaluation at 1 month after each embolization, 3-6 months after last embolization and efficacy 3-6 months after the last embolization treatment of dAVF with PHIL used with or without other embolization products (cyanoacrylate glue, coils, balloon, etc.).

71

Number of Patients

France (4)

Spain (4)

United Kingdom (2)

Sweden (2)

Denmark (1)

Design

Single arm prospective

Scope

All patients with an intracranial dAVF that has not been previously treated and will be treated by embolization with PHIL used with or without other embolization products .

Endpoints

Efficacy results

Assessment of cure rate and of clinical course of the patient (stable /improvement /deteriorated) at 3-6 months after last embolization compared to baseline
Cure rate assessment by Angiography

Safety results

Number of adverse events and assessment of neurological status at 1 month after each embolization compared to baseline

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03317821

SPONSOR Microvention-Terumo, Inc.

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PHIL cAVM

PHIL Evaluation in the Endovascular Treatment of Intracranial Cerebral ArterioVenous Malformation (cAVM)

Objectives

Assess efficacy and safety of PHIL® in endovascular embolization of cAVM.
Evaluate cure rate and safety outcome of cAVM treatment with PHIL based on initial treatment strategy.
Follow-up at 1Mo after each embolization session then at 3-6Mo post last embolization session.
Study set up to get reimbursement in France

20

Number of Patients

France (4)

Spain (4)

United Kingdom (2)

Sweden (1)

Denmark (1)

Design

Single arm prospective

Scope

All patients with a cAVM, ruptured or unruptured, eligible for EVT with PHIL, based on multidisciplinary consensus.

Endpoints

Efficacy results

Cure rate of cAVM with PHIL immediately after last embolization in all patients

Cure rate at 3-6 months in patients treated with EVT alone

Safety results

Clinical outcome compared to baseline by mRS at discharge, 1 month after each procedure and at 3-6 months after the final embolization in all patients performed by an independent neurologist.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03341039

SPONSOR Microvention-Terumo, Inc.

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Aneurysm Intravascular Treatment

FRED^TM
Flow Diverter

FRED US pivotal trial

Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms (FRED)

Objectives

To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA.

145

Number of Patients

United States (23)

Japan (1)

Design

Single arm prospective

Scope

Patients aged 22-75y.o., single target aneurysm located in the ICA,

Endpoints

Complete Occlusion with stenosis ≤50% and no retreatment within 12 months

Neurological Death or Major Ipsilateral Stroke at 12 months
Major stroke is defined as a new neurological event that persists for > 24 hours and results in a ≥ 4 points increase in the NIHSS score compared to baseline.
Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.

Efficacy results

Effectiveness achieved with PG of >46% aneurysm occlusion
Effectiveness endpoint was met in 80/139 (57.6%)

Safety results

Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant.
Safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%.

Study Publications

McDougall CG, Diaz O. et al. Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial. Neurintsurg-2021-017469

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01801007

SPONSOR Microvention-Terumo, Inc.

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FRED UK

Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment

Objectives

To demonstrate that use of the FRED/FRED Jr Embolic device in intracranil AN treatment is safe and effective when assessed at 1, 6 and 12 month post procedure.

61

Number of Patients

United Kingdom (7)

Design

Single arm prospective

Scope

Patients ≥18 y.o. presenting with an unruptured or recanalized IC aneurysm, from anterior circulation, requiring endovascular treatment, mRS≤2, eligible to be treated with FRED/FRED Jr.

Endpoints

Complete aneurysm occlusion without ˃ 50% parent artery stenosis at 6 months, evaluated by Corelab
Morbidity rate at 6 months, patients with mRS>2
Mortality rate at 6 months, patients with mRS=6

Efficacy results

At 6 months : rate of complete occlusion without associated stenosis of parent artey (>50%) = 63.3%

Adequate occlusion (12 months) = 86.4%”

Safety results

Morbidity (mRS<2) =0%
Mortality = 0%”

Study Publications

Article in preparation

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03423290

SPONSOR Microvention-Terumo, Inc.

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SAFE

Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment (SAFE)

Objectives

Assessment of safety and efficacy at 12-18Mo to obtain reimbursement in France

103

Number of Patients

France (13)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o. presenting with one unruptured or recanalized IC aneurysm, non acutely ruptured, from anterior circulation, requiring EVT, mRS≤2, eligible to be treated with FRED/FRED Jr

Endpoints

Aneurysm occlusion without ˃ 50% parent artery stenosis at 6 months
Morbidity rate at 6 months
Mortality rate at 6 months

Efficacy results

At 6Mo:

Complete occlusion without parent artery stenosis: 55.3%
Complete occluion: 61%

At 12Mo:

Complete occlusion without parent artery stenosis: 66.7%
Complete occluion: 73.3 %

Safety results

At 6Mo:

Morbidity (mRS>2): 2%
Mortality: 1%

At 12Mo:

Morbidity (mRS>2): 2.9%- 1 intraoperative TE, 1 Long term TE, 1 delayed AN ruptur
Mortality: 1.9%

Study Publications

Pierot, L., Spelle, L., Berge, J., et al. Feasibility, complications, morbidity, and mortality results at 6 months for aneurysm treatment with the Flow Re-Direction Endoluminal Device: report of SAFE Study. J NeuorIntervent Surg, 2018

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02921698

SPONSOR Microvention-Terumo, Inc.

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FRED Poland

Observational Study for Evaluation of the Safety and Performance of the MicroVention Flow Redirection Intraluminal Device (FRED Stent system) for the Treatment of Selected Intracranial

Objectives

Evaluation of the safety of the FRED throughout the complete follow-up period of 24 months and effectiveness of the FRED in the treatment of selected types of intracranial aneurysms in selected locations assessed at the 6- and 12-months follow-ups

86

Number of Patients

Poland (8)

Design

Single arm prospective

Scope

Patients with unruptured aneurysms from ICA segment C2-C6 or above PICA,

Endpoints

Primary effectiveness endpoint: percentage of aneurysms with successful isolation from the rest of the circulation and patency of FDV lumen at 6 and 12 months follow-up. The isolation will be classified in five possible levels by the imaging corelab.
Primary safety endpoint: rate of clinical complications (number of complications / number of stents implanted) after stent deployment classified by the Central Event Committee (CEC) as:
- early thromboembolic complications (during the first 3 months);
- late thromboembolic complications (between 3 and 24 months);
- haemorrhage from the treated aneurysm.”

Efficacy results

At 6Mo:

Complete occlusion without parent artery stenosis: 61.8%
Complete occluion: 64.9%

At 12Mo:

Complete occlusion without parent artery stenosis: 76.1%
Complete occluion: 79.5 %

At 24Mo:

Complete occlusion without parent artery stenosis: 82.5%
Complete occluion: 85.5 %

Safety results

Primary safety endpoint (Rate of clinical complications classified by the CEC as early thromboembolic complication, late thromboembolic complication or hemorrhage from the treated aneurysm) = 10.%
Rate of neurological permanent morbidity and mortality = 6.0%
All-cause mortality rate = 3.6%”

Study Publications

Results will be pooled in the FRED Meta-analysis

LINK TO STUDY PAGE

SPONSOR MVE

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Aneurysm Intravascular Treatment

LVIS^TM
Coil Assist Stent

LVIS Pivotal study

Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support) (LVIS)

Objectives

The pivotal US LVIS study is an IDE study designed to determine the safety and effectiveness of the LVIS device-supported coil embolization of WNAs located in the anterior and posterior intracranial circulations. Data from this study were used to support a US regulatory submission for premarket approval.

153

Number of Patients

United States (21)

Design

Single arm prospective

Scope

“Patient between 18-75y.o., with unruptured or ruptured (>30days) wide neck, saccular,intracranial aneurysm, ≥ 4mm and < 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio < 2).
Subject’s aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.”

Endpoints

Effectiveness Composite Success Number of Participants With Primary Effectiveness Composite Success (100% Aneurysm Occlusion Without Clinically Significant In-stent Stenosis or Target Aneurysm Retreatment) at 12 months
Safety Composite Rate (Disabling Stroke With mRS Score Greater Than or Equal to 3, or Neurological Death Within 12 Months

Efficacy results

Complete (100%) aneurysm occlusion and <50% stenosis of the treated artery at 12Mo by angiography evaluated by Corelab: 70.6%

Safety results

Rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12Mo: 5.2%

Study Publications

Fiorella D, Boulos A, Turk AS, Siddiqui AH, Arthur AS, Diaz O, Lopes DK; LVIS investigators. The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial. J Neurointerv Surg. 2019 Apr;11(4):357-361. doi: 10.1136/neurintsurg-2018-014309. Epub 2018 Oct 8.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01793792

SPONSOR Microvention-Terumo, Inc.

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LVIS Feasibility Study

Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device (LVIS)

Objectives

The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used to facilitate endovascular coiling of unruptured wide-neck intracranial aneurysms with bare platinum embolization coils.

30

Number of Patients

United States (6)

Design

Single arm prospective

Scope

Patient between 18-80y.o., with unruptured wide neck, saccular,intracranial aneurysm, < 20mm maximum diameter in any plane ( wide neck defined as neck width ≥ 4mm or dome to-neck ratio < 2).
Subject’s aneurysm arises from a parent vessel with a diameter of ≥ 2.5m and ≤ 4.5mm.

Endpoints

Probable Benefit Measures as Successful Aneurysm Treatment With the LVIS™ Device, as Measured by Aneurysm Angiographic Occlusion of ≥ 90% at 6 Months (± 4 Weeks)
Imaging to be reviewed by an independent core lab who will be comparing with baseline and post procedure images.
Safety Measures as Any Major Stroke or Death Within 30 Days, or Major Ipsi-lateral Stroke or Neurological Death Within 6 Months

Study Publications

Fiorella D, Arthur A, et al. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01541254

SPONSOR Microvention-Terumo, Inc.

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LEPI

Safety and Efficacy of the LVIS and LVIS JR Devices in the Endovascular Treatment of Intracranial Aneurysms

Objectives

Post reimbursement study evaluating morbi-mortality post procedure and at 1 year defined as AE with clinical sequelae and related to the device or the procedure

130

Number of Patients

France (20)

Design

Single arm prospective

Scope

All patients with aneurysms treated with LVIS/LVIS Jr in France

Endpoints

Mortality Rate at 1 year
Morbidity Rate at 1 year : Number of adverse events with clinical impact related to the procedure and/or the device

Efficacy results

All aneurysms (134/134, 100%) were successfully treated with LVIS stent and/or other devices. At a mean FU of 16.8 months post-procedure, complete/nearly complete occlusion was achieved in 112 aneurysms (92.6%), and only 3 patients (2.5%) required aneurysm retreatment.

Safety results

The cumulative morbidity and mortality rate (CMMR) at 1 year related to the procedure and/or device was 4.6% (6/130).
The overall mortality was 1.5% (2/130), none of these deaths adjudged as being linked to the procedure and/or device.

Study Publications

Forestier G. et al. Safety And Effectiveness Of The LVIS And LVIS Jr Devices For The Treatment Of Intracranial Aneurysms: Final Results Of The LEPI Multicenter Cohort Study. J Neuroradiol. 2023 Oct 17:S0150-9861(23)00253-5

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03553771

SPONSOR Microvention-Terumo, Inc.

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TRAIL

TRAIL: Treatment of Intracranial Aneurysms With LVIS® System (TRAIL)

Objectives

Assessment of safety and efficacy at 12-18Mo to obtain reimbursement in France

90

Number of Patients

France (9)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o. presenting with unruptured or ruptured, aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is < 2, WFNS (between 0 and 3), eligible to be treated with LVIS/LVIS Jr

Endpoints

“• Anatomical stability of aneurysm treatment compared to the initial occlusion rate of the aneurysm at 6 and 18 months
• Retreatment rate at 6 and 18 months
• Morbidity rate at 6 and 18 months
• Mortality rate at 6 and 18 months”

Efficacy results

At 6Mo:

100% stent stability
No parent artery stenosis: 100%
Complete occluion: 91%

At 18Mo:

100% stent stability
No parent artery stenosis: 100%
Complete occluion: 92.4 %
Retreatment: 2%

Safety results

At 6Mo:

Morbidity (mRS>2): 4.4%
Mortality: 2.2%-

At 18Mo:

Morbidity (mRS>2): 5.6%
Mortality: 5.6%- 2/5 device/procedure related

Study Publications

Iosif C, Piotin M, Saleme S, et al. Safety and effectiveness of the Low Profile Visualized Intraluminal Support (LVIS and LVIS Jr) devices in the endovascular treatment of intracranial aneurysms: results of the TRAIL multicenter observational study. J NeuroIntervent Surg, 2018

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02921711

SPONSOR Microvention-Terumo, Inc.

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Aneurysm Embolisation

WEB^TM
Intrasaccular Embolization

CLEVER

CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms (CLEVER)

Objectives

To assess clinical utility of WEB 17. Efficacy:Adequate occlusion at 12Mo
Safety: rate of death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.

163

Number of Patients

Germany (7)

France (6)

Finland (2)

United Kingdom (1)

Hungary (1)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o., but ≤ 80 y.o. requiring treatment for ruptured or unruptured IC aneurysms with WEB 0.017 only.

Endpoints

Aneurysm occlusion at 12 months
Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC)
Incidence of major stroke or neurological deaths at 12months :
The proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment

Safety results

* At the 12-month follow-up, major stroke events occurred in 3 of 163 patients (1.8%)

* Overall morbidity rates :
– at 1 month = 9/159 (5.7%)
– 1 year = 3/151 (2.0%)

* Overall mortality rates :
– at 1 month = 0%
– 1 year = 1/154 (0.6%) – No device-related mortality

Study Publications

CLinical EValuation of WEB 17 device in intracranial aneuRysms (CLEVER): procedural, 30-day and 1-year safety results for ruptured and unruptured aneurysms – J Neurointerv Surg. 2023 Nov 1:jnis-2023-020866. doi: 10.1136/jnis-2023-020866

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03844334

SPONSOR Microvention-Terumo, Inc.

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CLARYS

CLARYS: CLinical Assessment of WEB® Device in Ruptured aneurYSms (CLARYS)

Objectives

An observational non-randomized, multi-center, prospective assessment of the clinical utility of the WEB Aneurysm Embolization System in subjects with ruptured intracranial aneurysms deemed appropriate for endovascular treatment. The population being treated in this Registry is a subset of the CE marked indication.

60

Number of Patients

France (1)

Design

Single arm prospective

Scope

Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured intracranial aneurysms.
Intervention: Device: WEB Aneurysm Embolization System

Endpoints

Re-Bleed rate after treatment during the period extending from post-procedure up to 1 month. Definitions:

Re-bleeding from target aneurysm is defined as patent evidence of hemorrhage on CT or MRI AND hemorrhage is depicted in the same territory as the initial bleeding AND hemorrhage has increased in size compare to initial pre-operative CT
Screening for re-bleeding: During hospital stay of the patient and up to 1-month, any worsening of the clinical status should lead to perform a non-enhanced CT or MRI.

Or, as per-center standard care, non-enhanced CT or MRI might be performed systematically during hospital course.”

Study Publications

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study – Spelle L, et al. J NeuroIntervent Surg 2021;0:1–8. doi:10.1136/neurintsurg-2021-017416

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02687607

SPONSOR Microvention-Terumo, Inc.

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WEB French Observatory

WEB French Observatory of the WEB Aneurysm Embolization System

Objectives

Assessment of safety and efficacy at 1 year

61

Number of Patients

France (10)

Design

Single arm prospective

Scope

patients>18y.o.<75y.o., ruptured or unruptured AN, H&H<3

Endpoints

Efficacy :

Durability of aneurysm occlusion at 12 months
Durability of occlusion compared to post-procedure imaging

Efficacy results

At 12 Mo :

Complete occlusion: 51.7% / Adequate occlusion: 79.3%

Safety results

At 30 days:

Morbidity: 3.2%
Mortality: 0%

At 12 Mo:

Morbidity: 0%
Mortality:3.4%

Study Publications

Pierot L, et al.; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01975233

SPONSOR Microvention-Terumo, Inc.

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WEBCAST

Extension of WEBCAST study

Objectives

Assessment of efficacy, technical success, and safety up to 5 years

55

Number of Patients

France (5)

Hungary (1)

Germany (2)

Belgique (1)

Denmark (1)

Design

Single arm prospective

Scope

patients>18y.o.<75y.o., ruptured or unruptured AN, H&H<3

Endpoints

Durability of occlusion at 6 months

Efficacy results

At 6 Mo :

Complete occlusion: 57.1% / Adequate occlusion: 79.6%

At 12 Mo :

Complete occlusion: 54.0% / Adequate occlusion: 80.0%”

Safety results

At 30 days:

Morbidity: 3.6%
Mortality:0%

At 6 Mo and 12 Mo:

Morbidity: 3.9%
Mortality:2%”

Study Publications

Pierot L, et al. Safety and efficacy of aneurysm treatment with WEB: results of the WEBCAST 2 study. J Neurorad 2016;124:1250–6.

Pierot L, et al. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up. J Neurointerv Surg. 2021 Apr;13(4):363-368

LINK TO STUDY PAGE

SPONSOR Microvention-Terumo, Inc.

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WEBCAST

WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST)

Objectives

Assessment of safety and efficacy up to 5 years.

50

Number of Patients

France (5)

Hungary (1)

Germany (2)

Belgique (1)

Denmark (1)

Design

Single arm prospective

Scope

Patients>18y.o.<75y.o., with intracranial aneurysms

Endpoints

Durability of occlusion at 6 months

Efficacy results

At 6 Mo:

Primary endpoiint- Success:
Complete occlusion or stable neck remnant with no worsening from baseline and no retreatment performed or planned
– Rate of success : 79.6%
– Adequate occlusion: 85.4%

Safety results

At 30 days:

Morbidity: 2.0%
Mortality:0%

At 6 Mo:

Morbidity: 0%
Mortality:4.17%

Morbidity:

mRS > 2 if baseline ≤ 2
mRS +1 or more if baseline >2
mRS >2 and ruptured at baseline

Study Publications

Pierot L, et al.; WEBCAST and French Observatory Investigators. Clinical and Anatomical Follow-up in Patients With Aneurysms Treated With the WEB Device: 1-Year Follow-up Report in the Cumulated Population of 2 Prospective, Multicenter Series (WEBCAST and French Observatory). Neurosurgery. 2016 Jan;78(1):133-41

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01778322

SPONSOR Microvention-Terumo, Inc.

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Aneurysm Embolisation

HES
Coil

GREAT

Randomized controlled multicentre study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment

Objectives

To compare HydroSoft (including Hydroframe) versus bare platinum coils

484

Number of Patients

France

Germany (22)

Design

RCT

Scope

Patients aged 18-75 years presenting a cerebral aneurysm ruptured or unruptured
WFNS Grade 0-3
Aneurysm 4-12 mm in diameter

Endpoints

Primary outcome: Composite outcome of major aneurysm recurrence on follow-up angiography and clinical outcome within 18 months.
Secondary outcomes:
– Packing density
– Coil length deployed
– Clinical outcome at 6 and 18 months post-coiling, as measured by the modified Rankin scale”

Efficacy results

Unfavorable Composite (recurrence , retreatment,Morbidity) = 19,9% (HES) / 28,7% (BPC)
Complete occlusion at 18 Mo = 69% (HES) vs 53% (BPC)
Major recurrence = 12% (HES) vs 18% (BPC)
Retreatment rate = 3% (HES) vs 6% (BPC)”

Safety results

Procedural complications = 12.7% (HES) vs 12.4% (BPC)
The 14-day mortality rate = 2.0% (HES) vs 2.1% (BPC)
At 18 Mo: mRS 3-5 = 3% (HES) vs 1% (BPC)
mRS 6 = 3% (HES) vs 4% (BPC)
* Rupt. An. mRS 3-5 = 5% (HES) vs 2% (BPC)
mRS 6 = 5% (HES) vs 7% (BPC)
* Unrupt. An. mRS 3-5 = 1% (HES) vs 1% (BPC)
mRS 6 = 1% (HES) vs 2% (BPC)

Study Publications

Taschner C, Chapot R, Costalat V, et al. GREAT-a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment. Neuroradiology 2015;57:599-604.

LINK TO STUDY PAGE

SPONSOR Freiburg Hospital Germany

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COAST

COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils (COAST)

Objectives

To demonstrate that interventional treatment of small aneurysms using current coiling technology is safe and effective.

300

Number of Patients

United States (15)

Design

Single arm prospective

Scope

Patients w/small (≤ 4.9mm) aneurysms treated w/HyperSoft®/HyperSoft® 3D (Phase I) or HydroFrame®/HydroSoft® 3D (Phase II).

Endpoints

“Imaging outcomes (occlusion results) of small intracranial aneurysms as defined by the raymond Roy Grading scale at 48 hours :
To measure imaging outcomes of small (≤ 4.9 mm) intracranial aneurysms utilizing the HyperSoft® 3D (and HydroSoft® 3D, when commercially available) and HyperSoft® helical coils specifically designed for the treatment of small aneurysms.”

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02259504

SPONSOR Medical University of South Carolina

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HELPS

HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial)

Objectives

Compare safety and efficacy of HydroCoil vs platinum.

499

Number of Patients

United States

United Kingdom

Brazil

Germany

Australia

Argentina

France (24)

Design

RCT

Scope

Patients 18-75, ruptured or unruptured, 2-25mm. Hydrogel arm targeted to have > 50% packing w/gel or > 50% gel length deployed.

Endpoints

“Primary outcome: major aneurysm recurrence (Recurrence defined as adequate space in the aneurysm to deploy further coils)
Secondary outcomes: clinical outcome, rebleed, and retreatment rates”

Efficacy results

Adverse primary outcome: 28% HES vs 36% BPC (adverse outcome includes major recurrence and morbidity/mortality preventing angiographic f/u)
Major recurrence: 24% HES vs 33% BPC

Safety results

mRS ≥ 3 at 18 mo: 15.7% HES vs 12.8% BPC

Study Publications

White PM, Lewis SC, Nahser H, et al. HydroCoil Endovascular Aneurysm Occlusion and Packing Study (HELPS Trial): Procedural Safety and Operator-Assessed Efficacy Results. AJNR Am J Neuroradiol 2008;29:217-223.

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SPONSOR Microvention-Terumo, Inc.

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Gel-the-nec

Registry for Study of Coils in Intracranial Aneurysms (Gel-the-nec)

Objectives

Assess safety and efficacy of trearting aneurysms with HES coils used as finishing coils

599

Number of Patients

United States

United Kingdom

China

Korea

Japan (27)

Design

Single arm prospective

Scope

patients>20y.o.<91y.o., ruptured or unruptured AN 3-15mm, HydroSoft required as first attempt for all coils ≤ 3mm

Endpoints

We will compare recanalization or recurrence rates observed in this prospective registry of HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare platinum coils at 6 – 18 months post coiling

Efficacy results

Adequate occlusion: 88.4%
Recanalization: 10.8%
Retreat: 3.4%

Safety results

Procedure-related mortality: 0.5%
Procedure-related morbidity: 1.3%

Study Publications

Brinjikji W, Amar A, Almandoz J et al. GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device. J Neurointerv Surg 2017: Published online first January 10th, 2017 (Available on Seismic)

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01000675

SPONSOR Mayo Clinic

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HEAT

Hydrogel Endovascular Aneurysm Treatment Trial (HEAT)

Objectives

Compare recurrence between second generation of HES and bare platinum coils. Recurrence defined as any progression on Raymond Roy scale.

600

Number of Patients

United States (46)

Design

RCT

Scope

patients>18y.o.<75y.o., ruptured or unruptured AN 3-14mm, H&H<4

Endpoints

Number of Patients with Aneurysm Recurrence Post Surgery to 24 months
Defined as any progression on the Raymond-Roy (RR) Aneurysm Occlusion Scale.

Efficacy results

Aneurysm recurrence: 4.4% HES vs 15.4% BPC
Major recurrence (from R1 to R3, R2 to R3, R3): 12,8% vs 20,7%
Minor recurrence (from R1 to R2): 1% HES vs 5% BPC
Packing density: 32,5% HES vs 24,7% BPC (p<.001)
Initial complete occlusion: 17,8% HES vs 28,3% BPC
BUT at 3-12Mo: 64,9% HES vs 49% BPC
at 18-24Mo: 68,6% HES vs 51,5% BPC
Retreat: 5.2% HES vs 8.3% BPC

Safety results

AE related to procedure/device: 21.6% HES vs 24.8% BPC
Mortality: 2.4% HES vs 3.0% BPC
Device- or procedure-related hemorrhage: 1.7% vs 1.3%”

Study Publications

Abi-Aad K, Aoun R, Rahme R, et al. New generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): a study protocol for a multicenter randomized controlled trial. Neuroradiology, 2018.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT01407952

SPONSOR Northwestern University

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Mechanical Thrombectomy

SOFIA^TM
Aspiration Catheter

ERASER

ERic Acute StrokE Recanalization (ERASER)

Objectives

To monitor the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on artery recanalization and on clinical outcomes in stroke patients using data from clinical routine application (ERASER).
To additionally evaluate the effect of the ERIC® device in combination with SOFIA™ Distal Access Catheter on the final infarct volume as determined by advanced image postprocessing methods in the subgroup of patients with acute middle cerebral artery stroke (ERASER+).”

53

Number of Patients

Germany (8)

Switzerland (1)

Design

Single arm prospective

Scope

Patients over 18 year with acute ischemic stroke with NIH-SS score of 8-25, Intended usage of ERIC® as first device in combination with SOFIA™ Distal Access -Catheter (secondary bail-out with other devices allowed)

Endpoints

VOST (volume of saved tissue) = VPIv- VMT at 30 h :
volume of saved tissue (VOST) as difference of the brain volume with an infarct risk of >50%, based on a prediction- algorithm trained in a historical cohort treated with IV tPA (VPIv) and the actual infarct volume

Study Publications

ERASER A Thrombectomy Study With Predictive Analytics End Point – Fiehler J, Thomalla G, Bernhardt M, Kniep H, Berlis A, Dorn F, Eckert B, Kemmling A, Langner S, Remonda L, Reith W, Rohde S, Mohlenbruch M, Bendszus M, Forkert ND, Gellissen S. ERASER. Stroke. 2019 May;50(5):1275-1278. doi: 10.1161/STROKEAHA.119.024858.

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT02534701

SPONSOR Heidelberg Hospital - Universitätsklinikum Hamburg-Eppendorf

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SESAME

Safety and Effectiveness of SOFIA™/SOFIA™ PLUS for Direct Aspiration in Acute Ischemic Stroke (SESAME)

Objectives

To demonstrate that use of SOFIA/SOFIA PLUS catheter for direct aspiration as a first line treatment technique is fast, safe and effective in patients suffering an Acute Ischemic Stroke when assessed at 24 hours, discharge and 90 days after treatment.

250

Number of Patients

France (6)

Germany (5)

Austria (2)

Italy (1)

Netherlands (2)

Design

Single arm prospective

Scope

Patients ≥ 18 y.o. presenting with an acute stroke in the anterior cerebral circulation that can be treated within 6 hrs from AIS symptom onset. Those eligible to be treated with SOFIA/ SOFIA PLUS will be enrolled after having signed an informed consent form (or having one signed on his or her behalf by a legally authorized representative or an independent physician).

Endpoints

Clinical outcome at 90 days :
Dichotomization of patients into good functional outcome defined as a modified Rankin Score (mRS) ≤ 2 and bad functional outcome defined as mRS >2

Study Publications

Study analysis in process

LINK TO STUDY PAGE

ClinicalTrials.gov ID NCT03417349

SPONSOR Heidelberg Hospital - Dr. Markus Alfred Möhlenbruch

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Mechanical Thrombectomy

ERIC^TM
Stent Retriever

STABILISE

Stroke: an evaluation of thrombectomy in the ageing brain version 1 (STABILISE)

Objectives

“This study will investigate whether treatment using a purpose designed new clot retrieval device is at least as safe and effective in unblocking the occluded blood vessel after an acute ischaemic stroke as existing devices. The new device has design features that may be particularly useful in elderly patients with more difficult vascular access.
This study will investigate whether additional brain imaging would be helpful in acute stroke patients treated with clot retrieval by:
1. Examining whether analysis of blood vessels on the scans taken before treatment starts can predict who will or will not do well, and see if there is any link to age.
2. Detailed MRI brain scan 24h after treatment to see if scan findings at that stage can predict long term outcome, identify complications not appreciated on routine CT and see whether these are linked to patient age.”

66

Number of Patients

United Kingdom

Design

RCT

Scope

Endpoints

Feasibility and technical efficacy and safety of two novel thrombectomy devices – ERIC (a retriever device) and SOFIA (a distal access catheter) – used alone or in combination depending on operator preference.

Study Publications

Evaluation of stroke thrombectomy including patients where IV thrombolysis is contraindicated or has failed: a randomized trial of two novel thrombectomy devices – White PM, et al. J NeuroIntervent Surg 2021;13:311–317. doi:10.1136/neurintsurg-2020-016038

LINK TO STUDY PAGE

ClinicalTrials.gov number ISRCTN15698516

SPONSOR Biomedical Research Centre (UK)

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Mechanical Thrombectomy

BOBBY^TM
Balloon Guide Catheter

BOBBY STUDIE TEST

Objectives

10

Number of Patients

Design

Scope

Endpoints

LINK TO STUDY PAGE

SPONSOR Microvention-Terumo, Inc.

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