The WEB-IT Clinical Study

MicroVention

Status: Completed

Conditions: Wide Neck Bifurcation Intracranial Aneurysms; Intracranial Aneurysms

Treatments: Device: WEB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02191618

CP13-001

Details and patient eligibility

About

The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment. In this study, all patients with qualifying WNBAs will be treated with the WEB. The primary effectiveness outcome of the study is the likelihood of complete intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient whose age ≥18 and ≤75 years.
• Patient must have a single ruptured or unruptured IA (intracranial aneurysm) requiring treatment.
• Patient must sign and date an IRB/EC-approved written informed consent prior to initiation 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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150 participants in 1 patient group

WEB Aneurysm Embolization Device

Other 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.

Treatment:

Device: WEB