Clinical Trials in the USA / NCT06604884
Recruiting
Observational
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
NCT06604884 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Intracranial Aneurysm
Investigational drug(s) / intervention(s)
Treatment of Intracranial Aneurysms
Treatment of Intracranial Aneurysms: Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
Study 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
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.
Primary outcome measure(s)
- Incidence of the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure. — 1 Year
Incidence of complete occlusion of the target intracranial aneurysm (Raymond-Roy I) without significant parent artery stenosis (≤ 50%) nor re-treatment of the target intracranial aneurysm at 1-year post-procedure.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Baptist Medical Center Jacksonville | Jacksonville | Florida | Recruiting |
| Wellstar Research Institute | Marietta | Georgia | Recruiting |
| Endeavor Health | Evanston | Illinois | Recruiting |
| Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine | Carmel | Indiana | Recruiting |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | Recruiting |
| McLaren Healthcare | Flint | Michigan | Recruiting |
| Washington University in Saint Louis | St Louis | Missouri | Recruiting |
| Buffalo Medical Center | Buffalo | New York | Recruiting |
| Prisma Health | Greenville | South Carolina | Recruiting |
| Semmes Murphey Clinic/Semmes Murphy Foundation | Memphis | Tennessee | Recruiting |
More Medtronic Neurovascular Clinical Affairs trials in the USA
INSPIRE Pipeline™ Shield Post Approval Study
Active, not recruiting
Other trials for the same condition
INSPIRE Pipeline™ Shield Post Approval Study
Active, not recruiting
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Active, not recruiting
SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06604884 on ClinicalTrials.gov ↗ ← All trials in the USA