WEB™ Intrasaccular Embolization
WEB-IT: The WEB® Intrasaccular Therapy Study
"Five year follow-up data from the WEB-IT study demonstrated that the WEB device was safe and effective when used in the treatment of WNBAs. Aneurysm occlusion rates achieved at 1 year follow-up were durable, with rates of progressive thrombosis far exceeding rates of recurrence over time."
- Patients
150
- Countries
US, Turkey, Hungary, Germany, Canada, Denmark
- Clinical Centers
27
- Design
Single arm prospective
- Scope
Patients 18-75 y.o., with wide neck bifurcation intracranial aneurysms ruptured or unruptured, H&H<3, treatable with WEB only
- Purpose
Assessment of safety, efficacy and technical success of WEB up to 5 years.
1 year: Evaluate safety and effectiveness of WEB in support of an application for Food and Drug Administration approval in the USA.
Endpoints
Effectiveness:
Complete aneurysm occlusion without retreatment, recurrent SAH, without significant Parent Artery Stenosis (>50% stenosis) at 12 months (assessed by Corelab)
Safety:
Proportion of subjects with death of any nonaccidental cause or any major stroke within the first 30 days after treatment, or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
Efficacy results
At 12 months:
Complete occlusion: 53.8%
Adequate occlusion: 84.6%
Retreatment: 5.6%
Primary efficacy endpoint result: 54.8%
At 5 years:
Complete occlusion: 58.1%
Adequate occlusion: 87.2%
Retreatment: 15.5%
Safety results
At 12 months:
Mortality: 0%
Primary safety event: 0.7%
At 5 years:
New bleed or rebleed: 0%
Study publications
LINK TO STUDY PAGE Clinical Trials.gov ID NCT02191618
Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.
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WEB™ Intrasaccular Embolization
French Observatory: WEB™ French Observatory of the WEB Aneurysm Embolization System
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