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

Purpose

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.

Condition

  • Wide Neck Bifurcation Intracranial Aneurysms

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
WEB Aneurysm Embolization Device 		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.
  • Device: WEB
    Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms. Other Names: • WEB Aneurysm Embolization Device

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky, Department of Neurosurgery
Lexington, Kentucky 40536
Contact:
Rachel Norris
859-218-1644
rachel.norris@uky.edu

More Details

NCT ID
NCT04839705
Status
Recruiting
Sponsor
Microvention-Terumo, Inc.

Study Contact

Amy Bowles
714-482-8074
amy.bowles@microvention.com