NCT03207087

The WEB®-IT China Clinical Study

WEB® Intrasaccular Therapy Study China Clinical Trial Protocol

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-06-21
• Primary completion: 2021-01-30
• Completion: 2021-04-30
• First posted: 2017-07-02
• Last updated: 2020-10-23

Locations

8 sites across 1 country: China

Regulatory

• FDA-regulated device study