A Real-World Study of Intrasaccular Flow Disruption Devices for the Treatment of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients Treated With the Woven EndoBridge Device
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, safety, effectiveness, clinical appropriateness, and health economic outcomes will be collected according to the study protocol.
干预措施: Intrasaccular Flow Disruption Device (Device)
结局指标
主要结局
未指定
次要结局
- Proportion of Aneurysms With Adequate Occlusion Based on WEB Occlusion Scale(12 Months After the Index Procedure)
- Aneurysm Occlusion Status Based on Raymond-Roy Occlusion Classification and WEB Occlusion Scale(12 Months After the Index Procedure)
- Clinical Outcome Measured by Modified Rankin Scale(30 Days, 6 Months, and 12 Months After the Index Procedure)
研究者
Hongqi Zhang, MD
Xuanwu Hospital, Capital Medical University
Xuanwu Hospital, Beijing