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 Sex
- 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
Memorial Health Systems
Hollywood, Florida 33021
Hollywood, Florida 33021
Orlando Health Neuroscience Institute
Orlando, Florida 32806
Orlando, Florida 32806
The Queen's Medical Center Neuroscience Institute
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
Iowa City, Iowa 52242
University of Kansas Health System
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Baptist Health Systems
Lexington, Kentucky 40503
Lexington, Kentucky 40503
University of Kentucky, Department of Neurosurgery
Lexington, Kentucky 40536
Lexington, Kentucky 40536
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana 71103
Shreveport, Louisiana 71103
University of Maryland, Baltimore
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Johns Hopkins University
Baltimore, Maryland 21287
Baltimore, Maryland 21287
UMass Memorial Health
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
Abbott Northwestern Hospital Allina Health
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Montefiore Medical Center
Bronx, New York 10467
Bronx, New York 10467
Northshore University Hospital/Northwell Health
Manhasset, New York 11030
Manhasset, New York 11030
SUNY Stony Brook
Stony Brook, New York 11794
Stony Brook, New York 11794
Duke University
Durham, North Carolina 27710
Durham, North Carolina 27710
OhioHealth Research Institute
Columbus, Ohio 43214
Columbus, Ohio 43214
The Toledo Hospital d/b/a ProMedica Toledo Hospital
Toledo, Ohio 43606
Toledo, Ohio 43606
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Semmes Murphey
Memphis, Tennessee 38120
Memphis, Tennessee 38120
West Virginia University
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
More Details
- NCT ID
- NCT04839705
- Status
- Recruiting
- Sponsor
- Microvention-Terumo, Inc.