French Observatory Study:
WEB™ French Observatory of the WEB Aneurysm Embolization System
WEB™ Intrasaccular Embolization
"This comparative study shows increased use of WEB treatment in ruptured, small, and anterior communicating artery aneurysms when using WEB SL/SLS. There was a trend toward fewer thromboembolic complications with the WEB SL/SLS. With both the WEB DL and WEB SL/SLS, the treatment was safe, with low morbidity and no mortality."
- Patients
61
- Country
France
- Clinical Centers
10
- Design
Single arm prospective
- Scope
Patients 18-75 y.o., with bifurcation intracranial aneurysm, ruptured or unruptured, H&H<4, treatable with WEB DL or WEB.
- Purpose
Assessment of safety and efficacy at 1 year in an observatory registry.
Endpoints
Efficacy : Durability of aneurysm occlusion at 12 months compared to post-procedure imaging (assessed by Corelab)
Efficacy results
At 12 months:
Complete occlusion: 51.7% / Adequate occlusion: 79.3%
Safety results
At 30 days:
Morbidity: 3.2%
Mortality: 0%
At 12 months:
Morbidity: 0%
Mortality: 3.4%
Study publications
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT01975233
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