CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Completed

• Conditions: Brain Aneurysm

• Registration Number: NCT03844334
• Lead Sponsor: Microvention-Terumo, Inc.

Brief Summary

The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.

Detailed Description

All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.

Subjects will be followed per Institution's standard of care.

Study Timeline

• Study First Submitted: 2019-02-12
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-18
• Study Start: 2019-03-21
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

1. Subject must be ≥ 18 years of age and ≤80 years of age
2. Subject must have an intracranial aneurysm (IA),
3. Subject must sign and date Ethics Committee approved written informed consent prior to initiation of any clinical interventional procedures or when applicable, register the patient non opposition to the study data collection
4. For ruptured aneurysm, Subject with Hunt & Hess Score ≤ III

Exclusion Criteria

1. Subject has an IA with characteristics unsuitable for endovascular treatment
2. Subject's index IA was previously treated
3. Subject has stroke-in-evolution within the prior 30 days
4. An additional aneurysm must be treated during the procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aneurysm occlusion	12 months	Angiographic (conventional Angio) occlusion based on Raymond-Roy occlusion scale The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms.; * class I: complete obliteration; * class II: residual neck; * class III: residual aneurysm
Incidence of major stroke or neurological deaths	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

Trial Locations

Locations (4)

Universitätsklinikum Knappschaftskrankenhaus; 🇩🇪 Bochum, Germany

Hôpital Purpan; 🇫🇷 Toulouse, France

National Institute of Clinical Neurosciences; 🇭🇺 Budapest, Hungary

Hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France