Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device (WEB PAS)

MicroVention

Status: Enrolling

Conditions: Wide Neck Bifurcation Intracranial Aneurysms

Treatments: Device: WEB

Study type: Interventional

Funder types: Industry

Identifiers

NCT04839705

CL11010-001

Details and patient eligibility

About

A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Patient must be ≥ 18 at the time of screening
• Patient must have a single ruptured or unruptured IA requiring treatment
• Patient must sign and date an IRN approved written informed consent prior to initiation of any study procedures

Key Exclusion Criteria:

• Patient has an IA with characteristics unsuitable for endovascular treatment
• Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days
• Patient has had an SAH from a non-index IA or other intracranial hemorrhage within 90 days
• Patient 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)

---

180 participants in 1 patient group

WEB Aneurysm Embolization Device

Other group

Description:

WEB Aneurysm Embolization Device 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