INSPIRE Pipeline™ Shield Post Approval Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Treatment of Intracranial Aneurysms: Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™
Study summary
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.
Eligibility
Primary outcome measure(s)
- Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure. — 1 year
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.
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Yale New Haven Hospital | New Haven | Connecticut | |
| Baptist Medical Center Jacksonville | Jacksonville | Florida | |
| Emory University Hospital | Atlanta | Georgia | |
| Endeavor Health - Evanston Hospital | Evanston | Illinois | |
| Norton Healthcare | Louisville | Kentucky | |
| Washington University in Saint Louis | St Louis | Missouri | |
| NYU Langone Medical Center | New York | New York | |
| Montefiore Medical Center | New York | New York | |
| The Cleveland Clinic Foundation | Cleveland | Ohio | |
| Oklahoma (OU) University Medical Center | Oklahoma City | Oklahoma | |
| Geisinger Medical Center | Danville | Pennsylvania | |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | |
| Prisma Health | Greenville | South Carolina | |
| Baylor Scott & White Research Institute | Dallas | Texas | |
| University of Utah Hospital | Salt Lake City | Utah |
More Medtronic Neurovascular Clinical Affairs trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05071963 on ClinicalTrials.gov ↗ ← All trials in the USA