Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment
ConditionIntracranial Aneurysm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
Qualifiers
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.
Participants of any age and sex.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- Intrasaccular Flow Disruption Device
Treatment groups
1,000 Participants
are divided into 1 treatment groupSponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
Shenzhen Second People's Hospital
Collaborator
ZhuHai Hospital
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
Zhujiang Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
The First Medical Center of Chinese PLA General Hospital
Collaborator
Beijing Chao Yang Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Zhongnan Hospital
Collaborator
Tongji Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Huashan Hospital
Collaborator
Fudan University
Collaborator
RenJi Hospital
Collaborator
Ruijin Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Nanyang Central Hospital
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
The First Affiliated Hospital of Air Force Medicial University
Collaborator
The Second Affiliated Hospital of Air Force Military Medical University
Collaborator
Sichuan Provincial People's Hospital
Collaborator
West China Hospital
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
The Second Affiliated Hospital of Harbin Medical University
Collaborator
Xiangya Hospital of Central South University
Collaborator
The Second Xiangya Hospital, Central South University
Collaborator
The First Hospital of Jilin University
Collaborator
Second Hospital of Jilin University
Collaborator
Nanjing Gulou Hospital
Collaborator
First Hospital of China Medical University
Collaborator
Qilu Hospital of Shandong University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
The Affiliated Hospital Of Guizhou Medical University
Collaborator
First Affiliated Hospital of Fujian Medical University
Collaborator
MicroVention, Inc., a Terumo company
Collaborator
Anhui Provincial Hospital
Collaborator
Zhongshan Hospital of Hubei Province
Collaborator
Beijing Haidian Hospital
Collaborator
Peking University Third Hospital
Collaborator
Beijing Anzhen Hospital
Collaborator
Yichang Central People's Hospital
Collaborator
The General Hospital of Eastern Theater Command
Collaborator
The General Hospital of Northern Theater Command
Collaborator
Southwest Hospital, China
Collaborator
Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University
Collaborator
Affiliated Hospital of Yunnan University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
Tangshan Worker's Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Source ClinicalTrials.gov