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Pipeline Vantage device for treating brain aneurysms, followed after approval

Collects safety and effectiveness information on the Pipeline Vantage device in people with intracranial aneurysms.

Key facts

Who runs it
Medtronic Neurovascular Clinical Affairs
Where
Buffalo, Carmel, Evanston, Flint, Greenville, Iowa City, Jacksonville, Marietta, Memphis, and St Louis, United StatesSee the 10 sites
Trial code
Registry title
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
Status
Recruiting
People taking part
118 people, planned
Started
12 Dec 2025
Expected to end
Sept 2033
Type of study
Observational
Treatments tested
  • Treatment of Intracranial Aneurysms
Record updated
23 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a brain aneurysm (a bulge in a blood vessel in the brain) who are going to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.

Age
22 Years and older; must be an adult under local law at the time of consent.
Sex
All sexes can join.
Disease stage
An intracranial aneurysm (a bulge in a brain blood vessel) planned for treatment with the Pipeline™ Vantage Device.

Main reasons for not taking part

  • Any reason the device or procedure cannot be used, as listed in the local instructions for use.
  • May be unable to complete the study follow-up visits.
  • The study doctor thinks joining could harm the person's health.
  • Known to be pregnant, breastfeeding, or wishing to become pregnant during the study.
  • Taking part in another drug or device study that could affect the results.

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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
  • Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™
  • Patient is an adult per local law at time of consent

Who cannot take part

  • Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results
  • Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU
  • Patient who may be unable to complete the study follow-up
  • The Investigator determined that the health of the patient may be compromised by the patient's enrollment
  • Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study

Where in United States

  • Buffalo Medical CenterBuffalo, United StatesContact: Ellen CarlTaking people
  • Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and SpineCarmel, United StatesContact: Luke WatkinsTaking people
  • Endeavor HealthEvanston, United StatesContact: Maria BudzTaking people
  • McLaren HealthcareFlint, United StatesContact: Marci RobertsTaking people
  • Prisma HealthGreenville, United StatesContact: Shawn ManosTaking people
  • University of Iowa Hospitals and ClinicsIowa City, United StatesContact: Heena OlaldeTaking people
  • Baptist Medical Center JacksonvilleJacksonville, United StatesContact: Teresa NicolTaking people
  • WellStar Research InstituteMarietta, United StatesContact: Shelita KithcartTaking people
  • Semmes Murphey Clinic/Semmes Murphy FoundationMemphis, United StatesContact: Courtney BerrymanTaking people
  • Washington University in Saint LouisSt Louis, United StatesContact: Rachel ReedTaking people

About the trial

What the trial wants to find out

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.

Treatments tested

  • Treatment of Intracranial Aneurysms

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)
Plain-language title
Pipeline Vantage device for treating brain aneurysms, followed after approvalGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
23 October 2026