NCT03207087

Brief Summary

This trial is a prospective, multicenter, single-arm confirmatory clinical trial. The study is to confirm the safety and effectiveness of the WEB Aneurysm Embolization System demonstrated in the US WEB-IT Study for the treatment of intracranial wide-neck bifurcation aneurysms. The study's primary endpoints include a primary effectiveness endpoint and a primary safety endpoint. The study device must meet both endpoints. The primary effectiveness endpoint is adjudicated by an independent third party core lab.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
unknown

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 Start

First participant enrolled

June 21, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

3.6 years

First QC Date

June 26, 2017

Last Update Submit

October 21, 2020

Conditions

Wide Neck Bifurcation Intracranial Aneurysms

Outcome Measures

Primary Outcomes (2)

  • Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis

    Proportion of complete (angiographic) aneurysm occlusion as assessed by Core Lab without retreatment, recurrent subarachnoid hemorrhage, without significant parent artery stenosis (\>50% stenosis) at one year after treatment.

    12 month

  • Primary Safety Endpoint: Proportion of death and major stroke

    Proportion of death of any nonaccidental cause or any major stroke (defined as an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the National Institutes of Health Stroke Scale) within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment.

    12 month

Study Arms (1)

WEB Aneurysm Embolization Device

EXPERIMENTAL

The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. The intended therapeutic effect of the WEB device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant. Subjects will be screened for study eligibility after giving informed consent.

Device: WEB Aneurysm Embolization

Interventions

WEB Aneurysm EmbolizationDEVICE

Subjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques.

WEB Aneurysm Embolization Device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient whose age ≥ 18 and ≤75 years old
  • Patient must have a single ruptured or unruptured IA(intracranial aneurysm)requiring treatment
  • Patient must sign and date IRB/EC approved written informed consent prior to initiate of any study procedures

You may not qualify if:

  • Patient has an IA with characteristics unsuitable for endovascular treatment
  • Patient has stroke-in-evolution within the prior 60-days
  • Patient has had an SAH(subarachnoid hemorrhage) from a nonindex IA or any other intracranial hemorrhage within 90 days
  • Patient's index IA was previously treated
  • Patient is pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital)

Shanghai, Shanghai Municipality, China

Location

West China

Chengdu, Sichuan, China

Location

Tiantan Hospital

Beijing, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

The Second affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Huashan Hospital

Shanghai, China

Location

The General Hospital of Shenyang Military

Shenyang, China

Location

Tangdu Hospital, the Fourth Military Medical University

Xi'an, China

Location

Related Publications (1)

  • He C, Xu J, Gao X, Li G, Liang G, Jun Y, Zhao Z, Fang B, Xie X, Liu A, Zhang J, Zhang H, Liu J. Woven EndoBridge intrasaccular therapy for the treatment of unruptured wide-necked bifurcation aneurysms: a prospective study in a Chinese population. Chin Neurosurg J. 2026 Jan 20;12(1):2. doi: 10.1186/s41016-025-00418-2.

    PMID: 41559830DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2017

First Posted

July 2, 2017

Study Start

June 21, 2017

Primary Completion

January 30, 2021

Study Completion

April 30, 2021

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations

CN(8)