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INSPIRE Pipeline™ Shield Post Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05071963
Recruitment Status : Recruiting
First Posted : October 8, 2021
Last Update Posted : May 2, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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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.

Condition or disease Intervention/treatment
Intracranial Aneurysm 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 203 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Neurovascular Product Surveillance Registry (INSPIRE) Pipeline™ Flex Embolization Device With Shield Technology™ Post Approval Study (PAS)
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: Treatment of Intracranial Aneurysms
    Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™

Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071963


Contacts
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Contact: Medtronic Neurovascular Clinical Affairs 949-837-3700 rs.shieldpostapproval@medtronic.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jesse Jones, MD         
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Charles Matouk, MD         
United States, Florida
Baptist Medical Center Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Ricardo Hanel, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Brian Howard, MD         
United States, Kentucky
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40202
Contact: Tom Yao, MD         
United States, Missouri
Washington University in Saint Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Arindam Chatterjee, MD         
United States, New York
NYU Langone Medical Center Active, not recruiting
New York, New York, United States, 10016-6402
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Gabor Toth, MD         
United States, Oklahoma
Oklahoma (OU) University Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Hakeem Shakir, MD         
United States, Pennsylvania
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822-9800
Contact: Clemens Schirmer, MD         
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jan-Karl Burkhardt, MD         
United States, South Carolina
Prisma Health Recruiting
Greenville, South Carolina, United States, 29605
Contact: Mohammad I Chaudry, MD         
United States, Texas
Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75201
Contact: Ethan Benardete, MD         
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Study Director: Bruce Van Deman Medtronic
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT05071963    
Other Study ID Numbers: MDT16056
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: May 2, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be available

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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
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases