Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS)

Capital Medical University

Status: Not yet enrolling

Conditions: Intracranial Aneurysm

Treatments: Device: Intrasaccular Flow Disruption Device

Study type: Observational

Funder types: Other

Identifiers

NCT07620626

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Details and patient eligibility

About

This is a post-market, multicenter, real-world study of the commercially available Woven EndoBridge (WEB) device for the treatment of intracranial aneurysms. The study will collect clinical and imaging information from patients who receive WEB treatment as part of routine medical care. The purpose is to evaluate how well the aneurysm is closed after treatment and to assess the safety of the device in real-world clinical practice.

The study will include both retrospective and prospective patients. Participants will be followed according to routine clinical practice, including assessments after the procedure and at about 30 days, 6 months, and 12 months. The main outcomes are adequate aneurysm occlusion at 12 months and the rate of major adverse events within 1 year after treatment.

Full description

Intracranial aneurysms are abnormal dilatations of blood vessels in the brain. If an aneurysm ruptures, it can cause subarachnoid hemorrhage, which may lead to serious disability or death. Endovascular treatment has become an important treatment option for intracranial aneurysms. The Woven EndoBridge (WEB) device is an intrasaccular flow disruption device designed to treat selected intracranial aneurysms from within the aneurysm sac.

This study is a post-market, ambispective, multicenter, real-world registry study. It will evaluate the safety and performance of commercially available MicroVention WEB devices when used by treating physicians according to routine clinical practice and the approved instructions for use. The study does not assign participants to a treatment group and does not require a randomized comparison. Treatment decisions are made by the treating physicians based on standard medical care.

The study plans to enroll up to 1,000 patients from multiple study centers in China. Approximately 200 patients will be included retrospectively, and approximately 800 patients will be included prospectively. Eligible participants are patients with intracranial aneurysms treated with a commercially available WEB device. For the prospective cohort, written informed consent will be obtained from the participant or legally authorized representative before study-related data collection, as applicable.

Clinical data will be collected using an electronic data capture system. Imaging data will be de-identified and submitted for independent core laboratory assessment. Follow-up assessments are planned after the procedure and at approximately 30 days, 6 months, and 12 months. Follow-up may include neurological assessment, imaging evaluation, information on aneurysm retreatment, adverse event assessment, serious adverse event assessment, and information on antiplatelet or anticoagulant medication use.

The primary effectiveness outcome is the proportion of aneurysms with adequate occlusion at 12 months, based on the Raymond-Roy Occlusion Classification. Adequate occlusion is defined as Raymond-Roy class I or II. The primary safety outcome is the rate of major adverse events, including 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.

Other outcomes include aneurysm occlusion based on the WEB Occlusion Scale, aneurysm recurrence, aneurysm retreatment, rebleeding, parent artery patency, clinical outcome measured by the modified Rankin Scale, device-related serious adverse events, procedure-related serious adverse events, neurological events, and successful device implantation. The study will mainly use descriptive statistical methods to summarize outcomes and confidence intervals.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Patients Treated With the Woven EndoBridge Device

Description:

Patients with intracranial aneurysms who are treated with the commercially available MicroVention Woven EndoBridge device as part of routine clinical care. This cohort includes both retrospectively identified patients and prospectively enrolled patients. Clinical, procedural, imaging, and safety outcomes will be collected according to the study protocol.

Treatment:

Device: Intrasaccular Flow Disruption Device