Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment

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.

NCT Number	NCT07620626
Lead Sponsor	Xuanwu Hospital, Beijing Collaborators: Shenzhen Second People's Hospital, ZhuHai Hospital, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Guangdong Second Provincial General Hospital, Zhujiang Hospital, Nanfang Hospital, Southern Medical University, The First Medical Center of Chinese PLA General Hospital, Beijing Chao Yang Hospital, Beijing Tiantan Hospital, Zhongnan Hospital, Tongji Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Huashan Hospital, Fudan University, RenJi Hospital, Ruijin Hospital, Henan Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Nanyang Central Hospital, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Air Force Medicial University, The Second Affiliated Hospital of Air Force Military Medical University, Sichuan Provincial People's Hospital, West China Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Harbin Medical University, The Second Affiliated Hospital of Harbin Medical University, Xiangya Hospital of Central South University, The Second Xiangya Hospital, Central South University, The First Hospital of Jilin University, Second Hospital of Jilin University, Nanjing Gulou Hospital, First Hospital of China Medical University, Qilu Hospital of Shandong University, First Affiliated Hospital of Chongqing Medical University, People's Hospital of Guangxi Zhuang Autonomous Region, The Affiliated Hospital Of Guizhou Medical University, First Affiliated Hospital of Fujian Medical University, MicroVention, Inc., a Terumo company, Anhui Provincial Hospital, Zhongshan Hospital of Hubei Province, Beijing Haidian Hospital, Peking University Third Hospital, Beijing Anzhen Hospital, Yichang Central People's Hospital, The General Hospital of Eastern Theater Command, The General Hospital of Northern Theater Command, Southwest Hospital, China, Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University, Affiliated Hospital of Yunnan University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Tangshan Worker's Hospital, The Affiliated Hospital of Qingdao University
Conditions	Intracranial Aneurysm
Enrollment	1,000 participants
Start Date	2026-06-10
Primary Completion	2028-06-30 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-11