INSPIRE Pipeline™ Shield Post Approval Study

Last updated: January 10, 2025
Sponsor: Medtronic Neurovascular Clinical Affairs
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

Treatment of Intracranial Aneurysms

Clinical Study ID

NCT05071963
MDT16056 (Shield PAS)
  • Ages > 22
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Patient or legally authorized representative (LAR) provides authorization and/orconsent 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, asapplicable.

  4. 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).

  5. 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:

  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 studythat may confound the PSR results (i.e. no required intervention that could affectinterpretation of all-around product safety and/or effectiveness).

  4. Female patient who is known to be pregnant or is breastfeeding or wishes to becomepregnant during participation in the study.

  5. Patient is contraindicated for the device or procedure per the Pipeline™ ShieldDevice IFU.

  6. The Investigator determined that the health of the patient may be compromised by thepatient's enrollment.

  7. 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

Total Participants: 246
Treatment Group(s): 1
Primary Treatment: Treatment of Intracranial Aneurysms
Phase:
Study Start date:
December 20, 2021
Estimated Completion Date:
April 30, 2028

Study Description

The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use.

The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.

This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida 32207
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Endeavor Health - Evanston Hospital

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Norton Healthcare

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Washington University in Saint Louis

    Saint Louis, Missouri 63130
    United States

    Site Not Available

  • Montefiore Medical Center

    New York, New York 10467-2401
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016-6402
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oklahoma (OU) University Medical Center

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Geisinger Medical Center

    Danville, Pennsylvania 17822-9800
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Prisma Health

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Baylor Scott & White Research Institute

    Dallas, Texas 75201
    United States

    Site Not Available

  • University of Utah Hospital

    Salt Lake City, Utah 84132-0001
    United States

    Site Not Available

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