Who is eligible for clinical trial NCT05071963?

Participants must meet protocol criteria for Intracranial Aneurysm. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05071963 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-06

INSPIRE Pipeline™ Shield Post Approval Study (NCT05071963)

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Medtronic Neurovascular Clinical Affairs

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (8 items).

Location: University of Alabama at Birmingham — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (16 Sites)

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗