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NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

RecruitingObservational study

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

Who can join

Ages 22 and older · All sexes

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.

About the study

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.

What is being tested

Sponsor: Medtronic Neurovascular Clinical Affairs · Participants: 118 · Started: Dec 12, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06604884

Locations in the U.S.

FloridaBaptist Medical Center Jacksonville, Jacksonville
GeorgiaWellstar Research Institute, Marietta
IllinoisEndeavor Health, Evanston
IndianaAscension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine, Carmel
IowaUniversity of Iowa Hospitals and Clinics, Iowa City
MichiganMcLaren Healthcare, Flint
MissouriWashington University in Saint Louis, St Louis
South CarolinaPrisma Health, Greenville
TennesseeSemmes Murphey Clinic/Semmes Murphy Foundation, Memphis

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.