WEB™- IT China Study:
WEB™ Intrasaccular Therapy China Study
WEB™ Embolization System
WEB™- IT China study demonstrated that the "WEB™ device is safe and effective in the treatment of WNBAs in the Chinese population."
- Patients
60
- Country
China
- Clinical Centers
8
- Design
Single arm prospective
- Scope
Patients 18-75 years, with wide neck bifurcation intracranial aneurysms
- Purpose
Evaluate the safety and efficacy of the WEB™ device which is used to treat wide-neck bifurcation aneurysms
Endpoints
Effectiveness:
Complete aneurysm occlusion without retreatment, recurrent SAH, or > 50% stenosis in the parent artery 1 year after treatment.
Safety:
The proportion of patients with a major adverse event (MAE), a composite endpoint consisting of any non-accidental death or major stroke (≥ 4-point increase in NIHSS score) within 30 days of treatment or major ipsilateral stroke or neurological death from day 31 to 1 year after treatment.
Efficacy results
Technical success: 98.3%
At 12 months:
Complete occlusion: 56%
Adequate occlusion: 82%
Retreatments: 0%
Primary effectiveness endpoints: 54.2%
Safety results
At 6 months:
mRS 0-2: 98.3%
At 12 months:
Primary safety endpoint: 3.8%
Bleeding: 0%
Mortality: 0%
mRS 0-2: 100%
LINK TO STUDY PAGE: ClinicalTrials.gov ID NCT03207087
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MM2420 WW 09/26
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