RecruitingNot ApplicableNCT07407816

Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure

Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) Who May Benefit From Mechanical Circulatory Support Beyond the PCI Procedure


Sponsor

Supira Medical

Enrollment

45 participants

Start Date

Oct 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests the Supira heart support system in patients undergoing a high-risk heart procedure called percutaneous coronary intervention (PCI — a procedure to open blocked heart arteries) who also have existing heart failure. The device provides mechanical support to the heart during and beyond the procedure. **You may be eligible if...** - You have pre-existing heart failure (NYHA Class II, III, or IV) and a weakened heart (ejection fraction at or below 45%) - You have serious coronary artery disease: unprotected left main artery disease, last remaining open vessel, or three-vessel disease - Your doctor believes you could benefit from heart support beyond the procedure itself - You or your representative has given consent **You may NOT be eligible if...** - You had a stroke within the past 6 months or have permanent neurological damage from a prior stroke - You have moderate or severe aortic valve disease - You have severe liver disease or are on kidney dialysis - You have a history of heparin-induced low platelet count - You have a known bleeding disorder or blood clotting problems - You are pregnant or breastfeeding - You are currently enrolled in another device or drug trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESupira System

The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing high risk percutaneous coronary intervention (HRPCI). The Catheter is inserted percutaneously via the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.


Locations(2)

Tbilisi Heart and Vascular Clinic

Tbilisi, K'alak'i T'bilisi, Georgia

Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia

Tbilisi, Georgia

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NCT07407816


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