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NCT06604884From ClinicalTrials.govRecruiting

NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

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

  • Intracranial Aneurysm

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Medtronic Neurovascular Clinical Affairs
Enrolment target
118
Started
12 December 2025
Main results due
August 2029
Study sites
9
Registry updated
24 September 2026

Can you take part?

  • Aged 22 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(9)

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, United States

    Recruiting

  • Wellstar Research Institute

    Marietta, Georgia, United States

    Recruiting

  • Endeavor Health

    Evanston, Illinois, United States

    Recruiting

  • Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine

    Carmel, Indiana, United States

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, United States

    Recruiting

  • McLaren Healthcare

    Flint, Michigan, United States

    Recruiting

  • Washington University in Saint Louis

    St Louis, Missouri, United States

    Recruiting

  • Prisma Health

    Greenville, South Carolina, United States

    Recruiting

  • Semmes Murphey Clinic/Semmes Murphy Foundation

    Memphis, Tennessee, United States

    Recruiting

Showing 9 of 9 sites. 9 of the 9 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06604884. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study | Trialion