Phase
Condition
Aneurysm
Treatment
Treatment of Intracranial Aneurysms
Clinical Study ID
Ages > 22 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient or legally authorized representative (LAR) provides authorization and/orconsent 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, asapplicable.
Patient or patient's legally authorized representative (LAR) has provided writteninformed consent using the IRB and Medtronic approved Informed Consent Form andagrees to comply with the study requirements. HIPAA/data protection authorizationhas been provided and signed by the patient (or patient's LAR).
Patient has already been selected for endovascular treatment of the target aneurysmwith the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™Shield Device Instructions For Use (IFU).
Exclusion
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 studythat may confound the PSR results (i.e. no required intervention that could affectinterpretation of all-around product safety and/or effectiveness).
Female patient who is known to be pregnant or is breastfeeding or wishes to becomepregnant during participation in the study.
Patient is contraindicated for the device or procedure per the Pipeline™ ShieldDevice IFU.
The Investigator determined that the health of the patient may be compromised by thepatient's enrollment.
Patient is enrolled or planning to participate in a potentially confounding drug ordevice trial during the course of this study. Co-enrollment in concurrent trials isonly allowed when documented pre-approval was obtained from Medtronic.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Yale New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Baptist Medical Center Jacksonville
Jacksonville, Florida 32207
United StatesSite Not Available
Emory University Hospital
Atlanta, Georgia 30322
United StatesSite Not Available
Endeavor Health - Evanston Hospital
Evanston, Illinois 60201
United StatesSite Not Available
Norton Healthcare
Louisville, Kentucky 40202
United StatesSite Not Available
Washington University in Saint Louis
Saint Louis, Missouri 63130
United StatesSite Not Available
Montefiore Medical Center
New York, New York 10467-2401
United StatesSite Not Available
NYU Langone Medical Center
New York, New York 10016-6402
United StatesSite Not Available
The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesSite Not Available
Oklahoma (OU) University Medical Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822-9800
United StatesSite Not Available
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Prisma Health
Greenville, South Carolina 29605
United StatesSite Not Available
Baylor Scott & White Research Institute
Dallas, Texas 75201
United StatesSite Not Available
University of Utah Hospital
Salt Lake City, Utah 84132-0001
United StatesSite Not Available
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