INSPIRE Pipeline™ Shield Post Approval Study

Running, not enrolling

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID

NCT05071963

Run by

Medtronic Neurovascular Clinical Affairs

People needed

246

Starts

2021-12-20

Expected to finish

2028-04-01

Last updated by the study team

2026-02-27

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• 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
• Oklahoma (OU) University Medical Center — Oklahoma City, Oklahoma, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Prisma Health — Greenville, South Carolina, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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