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The WEB®-IT China Clinical Study

NCT03207087 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-23

No results posted yet for this study

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.

Conditions

  • Wide Neck Bifurcation Intracranial Aneurysms

Interventions

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.

Sponsors & Collaborators

  • Microvention-Terumo, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2021-01-30
Completion
2021-04-30
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207087 on ClinicalTrials.gov