Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS)

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Intrasaccular Flow Disruption Device

Detailed Description

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.

Other outcomes include aneurysm occlusion based on the WEB Occlusion Scale, aneurysm recurrence, aneurysm retreatment, rebleeding, parent artery patency, clinical outcome measured by the modified Rankin Scale, device-related serious adverse events, procedure-related serious adverse events, neurological events, successful device implantation and health economic outcomes. The study will mainly use descriptive statistical methods to summarize outcomes and confidence intervals.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Hongqi Zhang, M.D; Phone Number: +8613601374152; Email: xwzhanghq@163.com
• Study Contact Backup: Name: Xin Su, M.D; Phone Number: +8618210685023; Email: 1258940078@qq.com

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital
    • Contact: Simin Wang; Email: wsm158524@126.com
    • Principal Investigator: Hongqi Zhang
    • Sub-Investigator: Xin Su
    • Sub-Investigator: Simin Wang
    • Contact: Xin Su; Phone Number: +8618210685023; Email: 1258940078@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients with intracranial aneurysms who are treated with the commercially available MicroVention Woven EndoBridge device as part of routine clinical care at participating study centers in China. The registry includes both retrospectively identified patients and prospectively enrolled patients. Clinical, procedural, imaging, and safety data will be collected according to the study protocol.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: Woven EndoBridge; WEB Device; MicroVention WEB Device; Woven EndoBridge Aneurysm Embolization System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Major Adverse Events	Major adverse events include 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. Major stroke is defined as an ischemic or hemorrhagic stroke associated with an increase of more than 4 points in the NIHSS score.	Up to 1 Year After the Index Procedure
Proportion of Aneurysms With Adequate Occlusion Based on Raymond-Roy Occlusion Classification	Adequate aneurysm occlusion is defined as Raymond-Roy Occlusion Classification class I or II at the 12-month follow-up. Class I indicates complete occlusion, and class II indicates residual neck without contrast filling of the aneurysm sac.	12 Months After the Index Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aneurysm Occlusion Without Rebleeding in Ruptured Aneurysms	In participants with ruptured aneurysms, aneurysm occlusion status will be assessed together with the absence of rebleeding.	12 Months After the Index Procedure
Aneurysm Occlusion Without Rebleeding or Retreatment in Aneurysms With Residual Filling	In aneurysms with residual filling, occlusion status will be assessed together with absence of rebleeding in ruptured aneurysms or absence of retreatment.	12 Months After the Index Procedure
Stability of Aneurysm Occlusion	Occlusion stability will be assessed by comparing imaging results between the 6-month and 12-month follow-up visits and classified as unchanged, improved, or worsened.	From 6 Months to 12 Months After the Index Procedure
Aneurysm Recurrence	Aneurysm recurrence is defined as aneurysm growth or recanalization within 1 year after the index procedure.	Up to 1 Year After the Index Procedure
Aneurysm Retreatment	The proportion of participants who undergo retreatment of the target aneurysm within 1 year will be assessed.	Up to 1 Year After the Index Procedure
Unplanned Retreatment or Alternative Treatment	The proportion of participants who undergo unplanned retreatment or alternative treatment due to aneurysm recurrence or residual aneurysm will be assessed.	Up to 1 Year After the Index Procedure
Rebleeding Within 30 Days in Ruptured Aneurysms	In participants with ruptured aneurysms, rebleeding within 30 days after the procedure will be assessed, excluding intraprocedural rupture or bleeding.	Up to 30 Days After the Index Procedure
Rebleeding Within 1 Year in Ruptured Aneurysms	In participants with ruptured aneurysms, rebleeding within 1 year after the procedure will be assessed, excluding intraprocedural rupture or bleeding.	Up to 1 Year After the Index Procedure
New Bleeding of the Target Aneurysm in Unruptured Aneurysms	In participants with unruptured aneurysms, new bleeding of the target aneurysm within 1 year will be assessed, excluding intraprocedural rupture or bleeding.	Up to 1 Year After the Index Procedure
Parent Artery Patency	Parent artery patency will be assessed at 1 year, defined as less than 50% stenosis of the parent artery or absence of clinical symptoms.	12 Months After the Index Procedure
Device-Related Serious Adverse Events	Serious adverse events related to the study device will be collected and summarized.	Up to 1 Year After the Index Procedure
Procedure-Related Serious Adverse Events	Serious adverse events related to the procedure will be collected and summarized.	Up to 1 Year After the Index Procedure
Device- or Procedure-Related Adverse Events	Periprocedural and postprocedural adverse events related to the device or procedure will be collected and summarized.	Up to 1 Year After the Index Procedure
Neurological Events	Neurological events will include ischemic stroke, hemorrhagic stroke, neurological death, intracerebral hemorrhage, subarachnoid hemorrhage, arterial thrombosis, parent artery or branch artery perforation or rupture, and transient ischemic attack.	Up to 1 Year After the Index Procedure
Proportion of Aneurysms With Adequate Occlusion Based on WEB Occlusion Scale	Adequate aneurysm occlusion will be assessed by an independent imaging core laboratory using the Woven EndoBridge Occlusion Scale. The Woven EndoBridge Occlusion Scale is a categorical angiographic scale ranging from Class A to Class D: Class A indicates complete occlusion, Class B indicates complete occlusion with recess filling, Class C indicates neck remnant, and Class D indicates aneurysm remnant. Adequate occlusion is defined as Class A, Class B, or Class C. Class D indicates inadequate occlusion. This is a categorical scale; higher or lower numerical scores are not applicable.	12 Months After the Index Procedure
Aneurysm Occlusion Status Based on Raymond-Roy Occlusion Classification and WEB Occlusion Scale	Aneurysm occlusion status will be assessed by an independent imaging core laboratory using the Raymond-Roy Occlusion Classification and the Woven EndoBridge Occlusion Scale. The Raymond-Roy Occlusion Classification is a categorical angiographic classification ranging from Class I to Class III: Class I indicates complete occlusion, Class II indicates residual neck, and Class III indicates residual aneurysm. The Woven EndoBridge Occlusion Scale is a categorical angiographic scale ranging from Class A to Class D: Class A indicates complete occlusion, Class B indicates complete occlusion with recess filling, Class C indicates neck remnant, and Class D indicates aneurysm remnant. These are categorical scales; higher or lower numerical scores are not applicable.	12 Months After the Index Procedure
Clinical Outcome Measured by Modified Rankin Scale	Clinical outcome will be assessed using the Modified Rankin Scale (mRS). The Modified Rankin Scale is an ordinal scale ranging from 0 to 6, where 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcome.	30 Days, 6 Months, and 12 Months After the Index Procedure
Proportion of Target Aneurysms With Successful Woven EndoBridge Device Implantation	Successful device implantation will be assessed using the procedure record and electronic case report form. Successful Woven EndoBridge device implantation is defined as successful deployment and detachment of the Woven EndoBridge device in the target aneurysm during the index procedure. The outcome will be reported as the proportion of target aneurysms with successful device implantation among target aneurysms in which Woven EndoBridge device implantation was attempted. Reasons for unsuccessful implantation, such as inappropriate device size or model, unsuitable target aneurysm anatomy, unfavorable angle, vascular tortuosity preventing access to the lesion, or other reasons, will be recorded when applicable.	During the Index Procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare resource utilization	Healthcare resource utilization will be assessed by collecting data on procedure-related and follow-up medical resource use, including length of hospital stay, intensive care unit admission, additional procedures or retreatment, rehospitalization, emergency visits, outpatient visits, imaging examinations, and other aneurysm treatment-related healthcare services.	From the index procedure through 12 months after treatment
Health-related quality of life	Health-related quality of life will be assessed using protocol-specified patient-reported quality-of-life instruments. Changes in health-related quality-of-life scores from baseline to follow-up will be evaluated.	Baseline and 12 months after treatment

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Xiangya Hospital of Central South University; Fudan University; Beijing Tiantan Hospital; Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; RenJi Hospital; Huashan Hospital; Southwest Hospital, China; West China Hospital; Tongji Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital, School of Medicine, Zhejiang University; First Affiliated Hospital of Fujian Medical University; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Hospital of Qingdao University; Ruijin Hospital; Beijing Chao Yang Hospital; The First Affiliated Hospital of Zhengzhou University; Guangdong Provincial People's Hospital; Beijing Anzhen Hospital; Zhongnan Hospital; Zhujiang Hospital; The First Hospital of Jilin University; Henan Provincial People's Hospital; Third Affiliated Hospital, Sun Yat-Sen University; The Affiliated Hospital Of Guizhou Medical University; First Hospital of China Medical University; Shenzhen Second People's Hospital; The Second Affiliated Hospital of Harbin Medical University; Sichuan Provincial People's Hospital; Beijing Haidian Hospital; Second Hospital of Jilin University; First Affiliated Hospital of Chongqing Medical University; First Affiliated Hospital of Harbin Medical University; Anhui Provincial Hospital; Guangdong Second Provincial General Hospital; Yichang Central People's Hospital; ZhuHai Hospital; Nanyang Central Hospital; The General Hospital of Eastern Theater Command; The First Medical Center of Chinese PLA General Hospital; Tangshan Worker's Hospital; The Second Affiliated Hospital of Air Force Military Medical University; The General Hospital of Northern Theater Command; Affiliated Hospital of Yunnan University; The First Affiliated Hospital of Air Force Medicial University; Nanfang Hospital, Southern Medical University; People's Hospital of Guangxi Zhuang Autonomous Region; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; The Second Xiangya Hospital, Central South University; Guangxi Hospital of the First Affiliated Hospital, Sun Yat-sen University; Nanjing Gulou Hospital; MicroVention, Inc., a Terumo company; Zhongshan Hospital of Hubei Province
• Investigators: Study Chair: Hongqi Zhang, Xuanwu Hospital, Beijing; Study Director: Hongqi Zhang, Xuanwu Hospital, Beijing; Principal Investigator: Xin Su, Xuanwu Hospital, Beijing; Principal Investigator: Simin Wang, Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Active surveillance; Intracranial Aneurysm; Endovascular Treatment; Real-World Study; Woven EndoBridge; WEB Device; Intrasaccular Flow Disruption; Aneurysm Embolization; Post-Market Study; Raymond-Roy Occlusion Classification; WEB Occlusion Scale
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: xwzhqsxwsmhyf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes