An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.
Subjects will be screened for Observatory eligibility after giving informed consent. The embolization procedure will be performed in the digital angiographic suite using standard angiographic techniques. Initial analysis of Observatory data will be performed at completion of 12 month follow-up for the first thirty-five (35) subjects. Subjects will be followed per Institution's standard of care.
Study Type
OBSERVATIONAL
Enrollment
62
WEB Aneurysm Embolization System
CHU Pellegrin
Bordeaux, France
CHU Côte de Nacre
Caen, France
CHU Beaujon
Clichy, France
Hôpital Neurologique Pierre Wertheimer
Lyon, France
Durability of aneurysm occlusion
The following efficacy assessments will be performed to assess the efficacy of the WEB Aneurysm Embolization System in the endovascular treatment of aneurysms. 1\. Durability of occlusion compared to post-procedure imaging Durability is defined as: i. No worsening of Raymond Class from post-procedure result to follow-up result and ii. Not classified as "Recanalized"
Time frame: 12 months
Recurrence/recanalization rate
Rate of aneurysm recanalization
Time frame: 12 months
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Hôpital Nord Laennec
Nantes, France
CHU La Miletrie
Potiers, France
CHU Reims - Hôpital Maison-Blanche
Reims, France
CHU Pontchailloux
Rennes, France
CHU Purpan
Toulouse, France
CHU Bretonneau
Tours, France