Back to resultsThe WEB®-IT China Clinical Study (WEB-IT China)
Primary Purpose
Wide Neck Bifurcation Intracranial Aneurysms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
WEB Aneurysm Embolization
Sponsored by
About this trial
This is an interventional treatment trial for Wide Neck Bifurcation Intracranial Aneurysms
Eligibility Criteria
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
Sites / Locations
- Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital)
- West China
- Tiantan Hospital
- Xuanwu Hospital, Capital Medical University
- The Second affiliated Hospital of Zhejiang University School of Medicine
- Huashan Hospital
- The General Hospital of Shenyang Military
- Tangdu Hospital, the Fourth Military Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WEB Aneurysm Embolization Device
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03207087
First Posted
June 26, 2017
Last Updated
October 21, 2020
Sponsor
Microvention-Terumo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03207087
Brief Title
The WEB®-IT China Clinical Study
Acronym
WEB-IT China
Official Title
WEB® Intrasaccular Therapy Study China Clinical Trial Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 21, 2017 (Actual)
Primary Completion Date
January 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microvention-Terumo, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wide Neck Bifurcation Intracranial Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WEB Aneurysm Embolization Device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WEB Aneurysm Embolization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint: Complete (angiographic) aneurysm occlusion as assessed by Core Lab, without parent artery stenosis
Description
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
Title
Primary Safety Endpoint: Proportion of death and major stroke
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Changhai Hospital Affiliated to The Second Military Medical University ( Shanghai Changhai Hospital)
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tiantan Hospital
City
Beijing
Country
China
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
The Second affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
Huashan Hospital
City
Shanghai
Country
China
Facility Name
The General Hospital of Shenyang Military
City
Shenyang
Country
China
Facility Name
Tangdu Hospital, the Fourth Military Medical University
City
Xi'an
Country
China
12. IPD Sharing Statement
Learn more about this trial
The WEB®-IT China Clinical Study
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