Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI) (NCT07296744)
Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
🩺 Plain-English Summary (8th-Grade Level)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
Who can join: Review the eligibility criteria below.
Location: Loma Linda University Medical Center — Loma Linda, California
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- Loma Linda University Medical Center — Loma Linda, California
- UC Davis — Sacramento, California
- Los Robles Regional Medical Center — Thousand Oaks, California
- Piedmont Heart Institute — Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia
- Northwestern University — Chicago, Illinois
- Henry Ford Health / St. John Hospital — Detroit, Michigan
- CentraCare — Saint Cloud, Minnesota
- Washington University in St. Louis — St Louis, Missouri
- University of Buffalo (Buffalo General) — Buffalo, New York
- Cuimc/Nyph — New York, New York
- Montefiore Medical Center — The Bronx, New York
- OhioHealth — Columbus, Ohio
- Oklahoma Heart Hillcrest Medical — Tulsa, Oklahoma
- OHSU — Portland, Oregon
- University of Pennsylvania — Philadelphia, Pennsylvania
- Wellspan York Hospital — York, Pennsylvania
- Prisma Health — Columbia, South Carolina
- Baylor Scott & White The Heart Hospital — Plano, Texas
📞 Contact the Study Coordinator
Phone: (669) 330-0883
Email: clinical@supiramedical.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.