CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Microvention-Terumo, Inc.163 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

163

Conditions

Brain Aneurysm

Interventions

WEB Aneurysm Embolization SystemDEVICE

Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Hôpital Purpan

Toulouse, France

Universitätsklinikum Knappschaftskrankenhaus

Bochum, Germany

National Institute of Clinical Neurosciences

Budapest, Hungary

Outcomes

Primary Outcomes

Aneurysm occlusion

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

Time frame: 12 months

Incidence of major stroke or neurological deaths

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

Time frame: 12months

Data from ClinicalTrials.gov

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