CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-21

Study Completion Date

2022-08-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Brain Aneurysm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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WEB Aneurysm Embolization System

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No