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Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment
Sponsor: Xuanwu Hospital, Beijing
Summary
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. The study will include patients with IAs treated with commercially available WEB devices under the direction of treating physicians in routine clinical practice. Clinical, procedural, imaging, and safety data will be collected using a standardized electronic data capture system, with safety events adjudicated by an independent clinical events committee and imaging outcomes assessed by an independent core laboratory. The primary objective is to evaluate 12-month adequate aneurysm occlusion and major adverse events after WEB treatment. The study is expected to provide comprehensive post-market evidence on the real-world performance of the WEB device in China, including its safety, effectiveness, clinical appropriateness, and health economic value in routine neurointerventional practice.
Official title: A Real-World Study of Intrasaccular Flow Disruption Devices for the Treatment of Intracranial Aneurysms
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
1000
Start Date
2026-06-10
Completion Date
2028-06-30
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
Intrasaccular Flow Disruption Device
The intervention of interest is treatment of intracranial aneurysms using the commercially available MicroVention Woven EndoBridge device. The device is an intrasaccular flow disruption device used during endovascular treatment according to routine clinical practice and the approved instructions for use. Treatment decisions and procedural details are determined by the treating physician.
Locations (1)
Xuanwu Hospital
Beijing, China