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

MicroVention

Status: Unknown

Conditions: Wide Neck Bifurcation Intracranial Aneurysms

Treatments: Device: WEB Aneurysm Embolization

Study type: Interventional

Funder types: Industry

Identifiers

NCT03207087

CP-16-001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

WEB Aneurysm Embolization Device

Experimental group

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.

Treatment:

Device: WEB Aneurysm Embolization