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.
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Retrospective Cohort:
* Participants of any age and sex.
* Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
* Patients who completed at least one postoperative imaging follow-up.
Prospective Cohort:
* Participants of any age and sex.
* Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
* The participant, or legally authorized representative if applicable, understands the study requirements and procedures and provides written informed consent before any study-specific data collection.
Exclusion Criteria:
Retrospective Cohort:
* Patients treated with a Woven EndoBridge device for whom intraoperative or postoperative follow-up imaging data are not available.
* Patients considered by the investigator to be unsuitable for participation in this study.
Prospective Cohort:
* Participants who are currently participating in, or plan to participate during the follow-up period, another clinical study that may affect the results of this study.
* Patients who are currently unable or expected to be unable to complete follow-up.
* Patients with a life expectancy of less than 1 year due to other diseases or conditions.
* Patients considered by the investigator to be unsuitable for participation in this study.
Primary outcome measure(s)
Incidence of Major Adverse Events — Up to 1 Year After the Index Procedure Major adverse events include unexpected death or major stroke within 30 days after the procedure, and neurological death or major stroke from 31 days to 1 year after the procedure. Major stroke is defined as an ischemic or hemorrhagic stroke associated with an increase of more than 4 points in the NIHSS score.
Proportion of Aneurysms With Adequate Occlusion Based on Raymond-Roy Occlusion Classification — 12 Months After the Index Procedure Adequate aneurysm occlusion is defined as Raymond-Roy Occlusion Classification class I or II at the 12-month follow-up. Class I indicates complete occlusion, and class II indicates residual neck without contrast filling of the aneurysm sac.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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