The WEB®-IT China Clinical Study (WEB-IT China)

WEB® Intrasaccular Therapy Study China Clinical Trial Protocol

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 Overview

• Status: Unknown
• Conditions: Wide Neck Bifurcation Intracranial Aneurysms
• Intervention / Treatment: Device: WEB Aneurysm Embolization

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Tiantan Hospital
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University
  • Hangzhou, China
    • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Shanghai, China
    • Huashan Hospital
  • Shenyang, China
    • The General Hospital of Shenyang Military
  • Xi'an, China
    • Tangdu Hospital, The Fourth Military Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital)
  • Sichuan
    • Chengdu, Sichuan, China
      • West China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: WEB Aneurysm Embolization Device; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Microvention-Terumo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2017
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: June 29, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CP-16-001

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