Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
- Conditions
- Wide Neck Bifurcation Intracranial Aneurysms
- Interventions
- Device: WEB
- Registration Number
- NCT04839705
- Lead Sponsor
- Microvention-Terumo, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WEB Aneurysm Embolization Device WEB 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.
- Primary Outcome Measures
Name Time Method Key Effectiveness Outcome 12 Months Proportion of subjects with adequate aneurysm occlusion at one year after treatment.
Key Safety Outcome 12 Months Proportion of subjects with death of any nonaccidental cause or any major stroke\* within the first 30 days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to the 1 year after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Memorial Health Systems
🇺🇸Hollywood, Florida, United States
Orlando Health Neuroscience Institute
🇺🇸Orlando, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of Kansas Health System
🇺🇸Kansas City, Kansas, United States
Baptist Health Systems
🇺🇸Lexington, Kentucky, United States
University of Kentucky, Department of Neurosurgery
🇺🇸Lexington, Kentucky, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
LSU Health Sciences Center at Shreveport
🇺🇸Shreveport, Louisiana, United States
University of Maryland, Baltimore
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Massachusetts General Brigham Incorporated
🇺🇸Boston, Massachusetts, United States
UMass Memorial Health
🇺🇸Worcester, Massachusetts, United States
Abbott Northwestern Hospital Allina Health
🇺🇸Minneapolis, Minnesota, United States
The Washington University
🇺🇸Saint Louis, Missouri, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Northshore University Hospital/Northwell Health
🇺🇸Manhasset, New York, United States
SUNY Stony Brook
🇺🇸Stony Brook, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
OhioHealth Research Institute
🇺🇸Columbus, Ohio, United States
The Toledo Hospital d/b/a ProMedica Toledo Hospital
🇺🇸Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania Health Systems
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Semmes Murphey
🇺🇸Memphis, Tennessee, United States
Albany Medical Center
🇺🇸Albany, New York, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States