🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05071963
Active, not recruiting Observational

INSPIRE Pipeline™ Shield Post Approval Study

NCT05071963 · tracked via the Priya Life Science USA tracker
Sponsor
Medtronic Neurovascular Clinical Affairs
Phase
Observational
Started
2021-12-20
Last updated
2026-08-10

Condition(s) studied

Intracranial Aneurysm

Investigational drug(s) / intervention(s)

Treatment of Intracranial Aneurysms

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

Sex
ALL
Min age
22 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements. 2. Patient is intended to receive or be treated with an eligible Medtronic product. 3. Patient is consented within the enrollment window of the therapy received, as applicable. 4. 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). 5. 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). Exclusion Criteria: 1. Patient who is, or is expected to be, inaccessible for follow-up. 2. Participation is excluded by local law. 3. 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). 4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. 5. Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU. 6. The Investigator determined that the health of the patient may be compromised by the patient's enrollment. 7. 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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
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

Official registry record

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