INSPIRE Pipeline™ Shield Post Approval Study

Neurovascular Product Surveillance Registry (INSPIRE) Pipeline™ Flex Embolization Device With Shield Technology™ Post Approval Study (PAS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Treatment of Intracranial Aneurysms

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 246

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center Jacksonville
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Endeavor Health - Evanston Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Healthcare
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Washington University in Saint Louis
  • New York
    • New York, New York, United States, 10016-6402
      • NYU Langone Medical Center
    • New York, New York, United States, 10467-2401
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma (OU) University Medical Center
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-9800
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Prisma Health
  • Texas
    • Dallas, Texas, United States, 75201
      • Baylor Scott & White Research Institute
  • Utah
    • Salt Lake City, Utah, United States, 84132-0001
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Flex Embolization Device with Shield Technology™ device are eligible for the registry

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic Neurovascular Clinical Affairs
• Investigators: Study Director: Harsh Sancheti, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: MDT16056 (Shield PAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No