NCT07620626

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Jun 2028

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

May 27, 2026

Last Update Submit

June 9, 2026

Conditions

Intracranial Aneurysm

Keywords

Woven EndoBridgeWEB DeviceIntrasaccular Flow DisruptionEndovascular TreatmentIntracranial AneurysmAneurysm EmbolizationReal-World StudyPost-Market StudyRaymond-Roy Occlusion ClassificationWEB Occlusion ScaleActive surveillance

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (18)

  • Proportion of Aneurysms With Adequate Occlusion Based on WEB Occlusion Scale

    12 Months After the Index Procedure

  • Aneurysm Occlusion Status Based on Raymond-Roy Occlusion Classification and WEB Occlusion Scale

    12 Months After the Index Procedure

  • Aneurysm Occlusion Without Rebleeding in Ruptured Aneurysms

    12 Months After the Index Procedure

  • Aneurysm Occlusion Without Rebleeding or Retreatment in Aneurysms With Residual Filling

    12 Months After the Index Procedure

  • Stability of Aneurysm Occlusion

    From 6 Months to 12 Months After the Index Procedure

  • +13 more secondary outcomes

Other Outcomes (2)

  • Healthcare resource utilization

    From the index procedure through 12 months after treatment

  • Health-related quality of life

    Baseline and 12 months after treatment

Study Arms (1)

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

Interventions

Intrasaccular Flow Disruption DeviceDEVICE

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.

Also known as: Woven EndoBridge, WEB Device, MicroVention WEB Device, Woven EndoBridge Aneurysm Embolization System
Patients Treated With the Woven EndoBridge Device

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital

Beijing, 100053, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Hongqi Zhang

    Xuanwu Hospital, Beijing

    STUDY CHAIR

  • Hongqi Zhang

    Xuanwu Hospital, Beijing

    STUDY DIRECTOR

  • Xin Su

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

  • Simin Wang

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongqi Zhang, M.D

CONTACT

+8613601374152xwzhanghq@163.com

Xin Su, M.D

CONTACT

+86182106850231258940078@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Xuanwu Hospital, Capital Medical University

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations

CN(1)