The WEB®-IT China Clinical Study

N/AUnknownNCT03207087

Microvention-Terumo, Inc.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wide Neck Bifurcation Intracranial Aneurysms

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Shanghai, Shanghai Municipality, China

West China

Chengdu, Sichuan, China

Tiantan Hospital

Beijing, China

Xuanwu Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 12 month

Data from ClinicalTrials.gov

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