A Real-World Study of Intrasaccular Flow Disruption Devices for the Treatment of Intracranial Aneurysms
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.
⁃ 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.