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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Baptist Medical Center Jacksonville
  Jacksonville, Florida, United States Recruiting
• Wellstar Research Institute
  Marietta, Georgia, United States Recruiting
• Endeavor Health
  Evanston, Illinois, United States Recruiting
• Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine
  Carmel, Indiana, United States Recruiting
• University of Iowa Hospitals and Clinics
  Iowa City, Iowa, United States Recruiting
• McLaren Healthcare
  Flint, Michigan, United States Recruiting

Study contacts

• Study coordinator: Medtronic Neurovascular Clinical Affairs
• Email: rs.vantagepas@medtronic.com
• Phone: 949-837-3700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Collecting real-life data on endovascular treatments for brain aneurysms

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  Recruiting Microvention-Terumo, Inc. · Vigo, Pontevedra · NCT06494436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.