WEBCAST Study:
Clinical Assessment of IntraSaccular Aneurysm Therapy
WEB™ Intrasaccular Embolization
"This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB’s safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%)."
- Patients
50
- Countries
France, Hungary, Germany, Denmark
- Clinical Centers
10
- Design
Single arm prospective
- Scope
Patients 18-75 y.o., with wide neck bifurcation intracranial aneurysms ruptured or unruptured, H&H<4, treatable with WEB DL only
- Purpose
Assessment of safety, efficacy and technical success of WEB DL to 5 years.
Endpoints
Durability of occlusion at 6 months defined as complete occlusion or stable neck remnant with no worsening from baseline and no retreatment performed or planned (assessed by Corelab)
Efficacy results
At 6 months:
Primary endpoint = Complete occlusion or stable neck remnant with no worsening from baseline and no retreatment performed or planned: 79.6%
Adequate occlusion: 85.4%
Safety results
At 30 days:
Morbidity: 2.0%
Mortality: 0%
At 6 months:
Morbidity: 0%
Mortality: 4.2%
Study publications
LINK TO STUDY PAGE ClinicalTrials.gov ID NCT01778322
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