Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment

Summary

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.

Conditions

• Intracranial Aneurysm

Interventions

DEVICE

Intrasaccular Flow Disruption 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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• The First Medical Center of Chinese PLA General Hospital

  collaborator OTHER

• Beijing Chao Yang Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• Fudan University

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Ruijin Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Nanyang Central Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• The Second Affiliated Hospital of Air Force Military Medical University

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The Second Xiangya Hospital, Central South University

  collaborator UNKNOWN

• The First Hospital of Jilin University

  collaborator OTHER

• Second Hospital of Jilin University

  collaborator OTHER

• Nanjing Gulou Hospital

  collaborator UNKNOWN

• First Hospital of China Medical University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• The Affiliated Hospital Of Guizhou Medical University

  collaborator OTHER

• First Affiliated Hospital of Fujian Medical University

  collaborator OTHER

• MicroVention, Inc., a Terumo company

  collaborator UNKNOWN

• Anhui Provincial Hospital

  collaborator OTHER_GOV

• Zhongshan Hospital of Hubei Province

  collaborator UNKNOWN

• Beijing Haidian Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• Yichang Central People's Hospital

  collaborator OTHER

• The General Hospital of Eastern Theater Command

  collaborator OTHER

• The General Hospital of Northern Theater Command

  collaborator OTHER

• Southwest Hospital, China

  collaborator OTHER

• Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University

  collaborator UNKNOWN

• Affiliated Hospital of Yunnan University

  collaborator OTHER

• Second Affiliated Hospital, Zhejiang University, School of Medicine

  collaborator OTHER

• Tangshan Worker's Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Hongqi Zhang · Xuanwu Hospital, Beijing

• Hongqi Zhang · Xuanwu Hospital, Beijing

• Xin Su · Xuanwu Hospital, Beijing

• Simin Wang · Xuanwu Hospital, Beijing

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-10

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Device

Yes

Countries

• China

Study Locations