Status:
COMPLETED
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Lead Sponsor:
Microvention-Terumo, Inc.
Conditions:
Brain Aneurysm
Eligibility:
All Genders
18-80 years
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 appro...
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 wil...
Eligibility Criteria
Inclusion
- Subject must be ≥ 18 years of age and ≤80 years of age
- Subject must have an intracranial aneurysm (IA),
- 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
- For ruptured aneurysm, Subject with Hunt \& Hess Score ≤ III
Exclusion
- Subject has an IA with characteristics unsuitable for endovascular treatment
- Subject's index IA was previously treated
- Subject has stroke-in-evolution within the prior 30 days
- An additional aneurysm must be treated during the procedure
Key Trial Info
Start Date :
March 21 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT03844334
Start Date
March 21 2019
End Date
August 30 2022
Last Update
January 24 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
2
Hôpital Purpan
Toulouse, France, 31059
3
Universitätsklinikum Knappschaftskrankenhaus
Bochum, Germany, 44892
4
National Institute of Clinical Neurosciences
Budapest, Hungary, 1145