The WEB®-IT China Clinical Study

Not Applicable

• Conditions: Wide Neck Bifurcation Intracranial Aneurysms
• Interventions: Device: WEB Aneurysm Embolization

• Registration Number: NCT03207087
• Lead Sponsor: Microvention-Terumo, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-21
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23
• Primary Completion: 2021-01-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WEB Aneurysm Embolization Device	WEB Aneurysm Embolization	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.

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis	12 month	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.
Primary Safety Endpoint: Proportion of death and major stroke	12 month	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.

Trial Locations

Locations (8)

West China; 🇨🇳 Chengdu, Sichuan, China

Huashan Hospital; 🇨🇳 Shanghai, China

Tiantan Hospital; 🇨🇳 Beijing, China

Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital); 🇨🇳 Shanghai, Shanghai, China

The General Hospital of Shenyang Military; 🇨🇳 Shenyang, China

The Second affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Tangdu Hospital, the Fourth Military Medical University; 🇨🇳 Xi'an, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, China