Supira heart pump during and after high-risk heart artery procedures
Tests the Supira System, a heart-support device, in people with heart failure.
Plain-language title generated from the registry record
Registry title: Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
Key facts
- Where
- Tbilisi, GeorgiaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT07407816, who can take part
Where in Georgia
- Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi GeorgiaTbilisi, GeorgiaTaking people
- Tbilisi Heart and Vascular ClinicTbilisi, GeorgiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Supira Medical
- Trial code
- NCT07407816
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%; Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease; Subject may benefit from hemodynamic support beyond the index procedure; Informed consent granted by the patient or legally authorized representative.
Exclusion: Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit; Ongoing renal replacement therapy with dialysis or continues renal replacement therapy; Heparin-induced thrombocytopenia, current or any prior occurrences; Currently participating in active follow-up phase of another clinical study of an investigational drug or device; Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE); Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C); Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol; Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥1.5 in the absence of medication or known fibrinogen ≤1.5 g/L); Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE); Breastfeeding or pregnant; Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures.