NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

May 23, 2026 updated by: Medtronic Neurovascular Clinical Affairs

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

The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The INSPIRE Pipeline™ Vantage Post Approval Study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™.

This study is a sub-study to the Neurovascular Product Surveillance Registry (NCT02988128).

Study Type

Observational

Enrollment (Estimated)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Medical Center Jacksonville
        • Principal Investigator:
          • Ricardo Hanel
        • Contact:
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Indiana
      • Carmel, Indiana, United States, 46032-3318
        • Recruiting
        • Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine
        • Contact:
        • Principal Investigator:
          • Daniel Sahlein
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Michigan
      • Flint, Michigan, United States, 48532
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Semmes Murphey Clinic/Semmes Murphy Foundation
        • Contact:
        • Principal Investigator:
          • Violiza Inoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law.
  2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.
  3. Patient is an adult per local law at time of consent.

Exclusion Criteria:

  1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.
  2. Patient who may be unable to complete the study follow-up.
  3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
  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 currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 1 Year
Incidence of complete occlusion of the target intracranial aneurysm (Raymond-Roy I) without significant parent artery stenosis (≤ 50%) nor re-treatment of the target intracranial aneurysm at 1-year post-procedure.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Investigators

  • Study Director: Harsh Sancheti, Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

September 1, 2033

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 17, 2024

First Posted (Actual)

September 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT24028

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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