The WEB®-IT China Clinical Study

Wide Neck Bifurcation Intracranial Aneurysms Clinical Trial

— WEB-IT China  

Official title:

WEB® Intrasaccular Therapy Study China Clinical Trial Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03207087
• Other study ID #: CP-16-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2017
• Est. completion date: April 30, 2021

Study information

• Verified date: October 2020
• Source: Sequent Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Wide Neck Bifurcation Intracranial Aneurysms

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sequent Medical, Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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