NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

Recruiting now

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID

NCT06604884

Run by

Medtronic Neurovascular Clinical Affairs

People needed

118

Starts

2025-12-12

Expected to finish

2033-09-01

Last updated by the study team

2026-06-23

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.

Where it is running

• Baptist Medical Center Jacksonville — Jacksonville, Florida, United States (enrolling)
• Wellstar Research Institute — Marietta, Georgia, United States (enrolling)
• Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine — Carmel, Indiana, United States (enrolling)
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
• McLaren Healthcare — Flint, Michigan, United States (enrolling)
• Prisma Health — Greenville, South Carolina, United States (enrolling)
• Semmes Murphey Clinic/Semmes Murphy Foundation — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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