Actively Recruiting
Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
Led by Supira Medical · Updated on 2026-02-17
45
Participants Needed
2
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have pre-existing heart failure with NYHA Class II, III, or IV before admission and left ventricular ejection fraction (LVEF) of 45% or less
- Present with unprotected left main coronary artery disease, last patent vessel disease, or three-vessel disease
- May benefit from hemodynamic support beyond the PCI procedure
- Provide informed consent by the patient or legally authorized representative
You will not qualify if you...
- Had a stroke within 6 months or any prior stroke causing permanent neurological deficit
- Have moderate or greater aortic valve disease or regurgitation (2+ or higher on a 4-grade scale)
- Have moderate or greater aortic stenosis or regurgitation (mean gradient over 20 mmHg or valve area less than 1.5 cm2)
- Have decompensated liver disease or severe liver dysfunction (Child-Pugh Score class C)
- Are on ongoing dialysis or continuous renal replacement therapy
- Have current or past heparin-induced thrombocytopenia
- Have known allergies to intravenous contrast agents that cannot be pre-medicated, or to heparin, aspirin, ADP receptor inhibitors, or nitinol
- Have known or suspected blood clotting disorders or abnormal clotting parameters
- Are pregnant or breastfeeding
- Are currently in active follow-up for another investigational drug or device study
- Have medical, social, or psychological issues that prevent informed consent or study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Tbilisi Heart and Vascular Clinic
Tbilisi, K'alak'i T'bilisi, Georgia, 0112
Actively Recruiting
2
Israeli-Georgian Medical Research Clinic HealthyCore 13g Tevdore-Mghvdeli Street Tbilisi Georgia
Tbilisi, Georgia
Actively Recruiting
Research Team
C
Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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