The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.
The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use. The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S. This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).
Study Type
OBSERVATIONAL
Enrollment
246
Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™
University of Alabama at Birmingham
Birmingham, Alabama, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
Incidence at 1-year post-procedure of complete occlusion of the target aneurysm, significant parent artery stenosis ≤ 50%, and no retreatment of the target aneurysm.
Time frame: 1 year
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Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Endeavor Health - Evanston Hospital
Evanston, Illinois, United States
Norton Healthcare
Louisville, Kentucky, United States
Washington University in Saint Louis
St Louis, Missouri, United States
NYU Langone Medical Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
...and 6 more locations