Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment

ConditionIntracranial Aneurysm

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorXuanwu Hospital, Beijing

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Participants of any age and sex.

Disqualifiers

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.

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.

Trial population

The study population includes patients with intracranial aneurysms who are treated with the commercially available MicroVention Woven EndoBridge device as part of routine clinical care at participating study centers in China. The registry includes both retrospectively identified patients and prospectively enrolled patients. Clinical, procedural, imaging, and safety data will be collected according to the study protocol.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Intrasaccular Flow Disruption Device
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.

Treatment groups

1,000 Participants

are divided into 1 treatment group

Group A: Patients Treated With the Woven EndoBridge Device1 intervention

Trial outcomes

Primary outcomes

Incidence of Major Adverse Events

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.

Time frame

Up to 1 Year After the Index Procedure

Proportion of Aneurysms With Adequate Occlusion Based on Raymond-Roy Occlusion Classification

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.

Time frame