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Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)

Study testing the SUpira System for high-risk heart procedures.

Recruiting
18-90 years
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study looks at how safe and effective the Supira System is for helping the heart during a special procedure called High-Risk Percutaneous Coronary Intervention (HRPCI). The Supira System is a small device put into the body through a blood vessel in the leg (the femoral artery) to help the heart pump blood for up to 4 hours. It is compared with another device called the Impella. During the study, doctors will decide if the Supira System or Impella is better for patients who need extra heart support.

  • The study involves using the device for a short time during the HRPCI procedure.
  • Participants must not have serious heart issues, liver disease, or other severe health problems.
  • Patients who are pregnant or in another medical study cannot join this study.
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Study details
    Coronary Artery Disease
    High Risk Percutaneous Coronary Intervention
    Interventional Cardiology
    Mechanical Circulatory Support

NCT07296744

Supira Medical

30 May 2026

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