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
| Arm | Description | Assigned 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. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
University of Kentucky, Department of Neurosurgery
Lexington, Kentucky 40536
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT04839705
- Status
- Recruiting
- Sponsor
- Microvention-Terumo, Inc.