RecruitingNCT06604884

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)

Sponsor

Medtronic Neurovascular Clinical Affairs

Enrollment

118 participants

Start Date

Dec 12, 2025

Study Type

OBSERVATIONAL

Conditions

Intracranial Aneurysm

Summary

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.

Eligibility

Min Age: 22 Years

Inclusion Criteria3

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.

Exclusion Criteria5

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.