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 4158928, Florida 4155751 33021
Hollywood 4158928, Florida 4155751 33021
Orlando Health Neuroscience Institute
Orlando 4167147, Florida 4155751 32806
Orlando 4167147, Florida 4155751 32806
The Queen's Medical Center Neuroscience Institute
Honolulu 5856195, Hawaii 5855797 96813
Honolulu 5856195, Hawaii 5855797 96813
University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
University of Kansas Health System
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Baptist Health Systems
Lexington 4297983, Kentucky 6254925 40503
Lexington 4297983, Kentucky 6254925 40503
University of Kentucky, Department of Neurosurgery
Lexington 4297983, Kentucky 6254925 40536
Lexington 4297983, Kentucky 6254925 40536
LSU Health Sciences Center at Shreveport
Shreveport 4341513, Louisiana 4331987 71103
Shreveport 4341513, Louisiana 4331987 71103
University of Maryland, Baltimore
Baltimore 4347778, Maryland 4361885 21201
Baltimore 4347778, Maryland 4361885 21201
Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287
Baltimore 4347778, Maryland 4361885 21287
UMass Memorial Health
Worcester 4956184, Massachusetts 6254926 01655
Worcester 4956184, Massachusetts 6254926 01655
Abbott Northwestern Hospital Allina Health
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55407
The Washington University
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
Albany Medical Center
Albany 5106834, New York 5128638 12208
Albany 5106834, New York 5128638 12208
University of Buffalo
Buffalo 5110629, New York 5128638 14203
Buffalo 5110629, New York 5128638 14203
Northshore University Hospital/Northwell Health
Manhasset 5125766, New York 5128638 11030
Manhasset 5125766, New York 5128638 11030
SUNY Stony Brook
Stony Brook 5139865, New York 5128638 11794
Stony Brook 5139865, New York 5128638 11794
Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467
The Bronx 5110266, New York 5128638 10467
Duke University
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
Ohio State University
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
OhioHealth Research Institute
Columbus 4509177, Ohio 5165418 43214
Columbus 4509177, Ohio 5165418 43214
The Toledo Hospital d/b/a ProMedica Toledo Hospital
Toledo 5174035, Ohio 5165418 43606
Toledo 5174035, Ohio 5165418 43606
University of Oklahoma Health Sciences Center
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
University of Pennsylvania Health Systems
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
Semmes Murphey
Memphis 4641239, Tennessee 4662168 38120
Memphis 4641239, Tennessee 4662168 38120
West Virginia University
Morgantown 4815352, West Virginia 4826850 26506
Morgantown 4815352, West Virginia 4826850 26506
More Details
- NCT ID
- NCT04839705
- Status
- Recruiting
- Sponsor
- Microvention-Terumo, Inc.