INSPIRE Pipeline™ Shield Post Approval Study
Neurovascular Product Surveillance Registry (INSPIRE) Pipeline™ Flex Embolization Device With Shield Technology™ Post Approval Study (PAS)
1 other identifier
observational
246
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2021
CompletedFirst Posted
Study publicly available on registry
October 8, 2021
CompletedStudy Start
First participant enrolled
December 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 27, 2026
February 1, 2026
4.5 years
September 28, 2021
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
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.
1 year
Interventions
Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™
Eligibility Criteria
Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Flex Embolization Device with Shield Technology™ device are eligible for the registry
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Baptist Medical Center Jacksonville
Jacksonville, Florida, 32207, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Endeavor Health - Evanston Hospital
Evanston, Illinois, 60201, United States
Norton Healthcare
Louisville, Kentucky, 40202, United States
Washington University in Saint Louis
St Louis, Missouri, 63130, United States
NYU Langone Medical Center
New York, New York, 10016-6402, United States
Montefiore Medical Center
New York, New York, 10467-2401, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oklahoma (OU) University Medical Center
Oklahoma City, Oklahoma, 73104, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822-9800, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Prisma Health
Greenville, South Carolina, 29605, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75201, United States
University of Utah Hospital
Salt Lake City, Utah, 84132-0001, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Harsh Sancheti
Medtronic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2021
First Posted
October 8, 2021
Study Start
December 20, 2021
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
April 1, 2028
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
No individual participant data will be available