INSPIRE Pipeline™ Shield Post Approval Study
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT05071963
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- Brief 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 246
- Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- Patient is intended to receive or be treated with an eligible Medtronic product.
- Patient is consented within the enrollment window of the therapy received, as applicable.
- Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR).
- Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU).
- Patient who is, or is expected to be, inaccessible for follow-up.
- Participation is excluded by local law.
- Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
- Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
- Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU.
- The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
- Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Montefiore Medical Center
🇺🇸New York, New York, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Baylor Scott & White Research Institute
🇺🇸Dallas, Texas, United States
Baptist Medical Center Jacksonville
🇺🇸Jacksonville, Florida, United States
Oklahoma (OU) University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Endeavor Health - Evanston Hospital
🇺🇸Evanston, Illinois, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Washington University in Saint Louis
🇺🇸Saint Louis, Missouri, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States