Pipeline Vantage post-approval safety and outcomes for intracranial aneurysm treatment

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

This project will test whether the Pipeline Vantage embolization device with Shield Technology is safe and effective for adults treated for intracranial aneurysms.

Quick facts

• Study type: Observational
• Enrollment: 118 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Medtronic Neurovascular Clinical Affairs (Industry-sponsored)
• Locations: 4 sites (Marietta, Georgia and 3 other locations)
• Trial ID: NCT06604884 on ClinicalTrials.gov

What this trial studies

The INSPIRE Pipeline Vantage post-approval study is a prospective, multicenter, single-arm registry sub-study designed to collect real-world safety and effectiveness data on the Pipeline Vantage Embolization Device with Shield Technology. Adults treated with the device at participating centers are enrolled and followed using a standardized protocol to capture procedural results, complications, and longer-term aneurysm occlusion outcomes. Data are collected in a post-approval setting to complement premarket evidence and reflect routine clinical practice. The study uses the Neurovascular Product Surveillance Registry infrastructure to support enrollment and longitudinal follow-up across multiple U.S. sites.

Who should consider this trial

Good fit: Adults with an intracranial aneurysm intended to be treated with the Pipeline Vantage device who can provide informed consent and meet the device instructions-for-use are ideal candidates.

Not a fit: Patients with contraindications per the device IFU, those who are pregnant or breastfeeding, or those unable to complete follow-up may not receive benefit from participation.

Why it matters

Potential benefit: If successful, the study could confirm that the device provides safe, durable aneurysm occlusion in routine clinical practice and help inform treatment decisions.

How similar studies have performed: Earlier premarket trials and registry data for Pipeline family flow-diverters have shown effectiveness, and this post-approval work builds on that existing evidence.

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.

Where this trial is running

Marietta, Georgia and 3 other locations

• Wellstar Research Institute — Marietta, Georgia, United States (Recruiting)
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (Recruiting)
• McLaren Healthcare — Flint, Michigan, United States (Recruiting)
• Semmes Murphey Clinic/Semmes Murphy Foundation — Memphis, Tennessee, United States (Recruiting)

Study contacts

• Study coordinator: Medtronic Neurovascular Clinical Affairs

Conditions Intracranial Aneurysm