The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.
The INSPIRE Pipeline™ Vantage Post Approval Study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™. This study is a sub-study to the Neurovascular Product Surveillance Registry (NCT02988128).
Study Type
OBSERVATIONAL
Enrollment
118
Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
Baptist Medical Center Jacksonville
Jacksonville, Florida, United States
RECRUITINGWellstar Research Institute
Marietta, Georgia, United States
RECRUITINGAscension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine
Carmel, Indiana, 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 of complete occlusion of the target intracranial aneurysm (Raymond-Roy I) without significant parent artery stenosis (≤ 50%) nor re-treatment of the target intracranial aneurysm at 1-year post-procedure.
Time frame: 1 Year
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
RECRUITINGMcLaren Healthcare
Flint, Michigan, United States
RECRUITINGSemmes Murphey Clinic/Semmes Murphy Foundation
Memphis, Tennessee, United States
RECRUITING