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Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Sponsor: Microvention-Terumo, Inc.
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.
Official title: Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
195
Start Date
2022-08-24
Completion Date
2030-05
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
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
Locations (27)
Memorial Health Systems
Hollywood, Florida, United States
Orlando Health Neuroscience Institute
Orlando, Florida, United States
The Queen's Medical Center Neuroscience Institute
Honolulu, Hawaii, 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
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
St Louis, Missouri, United States
Albany Medical Center
Albany, 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
Montefiore Medical Center
The Bronx, 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
West Virginia University
Morgantown, West Virginia, United States