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COMPLETEDNCT03844334

CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms

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 appro...

Lead sponsor: Microvention-Terumo, Inc.•4 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Microvention-Terumo, Inc.

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.

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 24, 2024Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment163

Start dateMar 2019

Last updatedJan 24, 2024

Condition

Locations shown

Hôpital Bicêtre

Le Kremlin-Bicêtre

Hôpital Purpan

Toulouse

Universitätsklinikum Knappschaftskrankenhaus

Bochum

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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