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)
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.
Trial sites (16)
Facility
City
Region
Status
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
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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.
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