Actively Recruiting
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
Led by Supira Medical · Updated on 2026-02-17
45
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of the Supira System in patients with heart failure and low left ventricular ejection fraction (LVEF) who are undergoing high-risk percutaneous coronary intervention (HRPCI). This study focuses on those with severe coronary artery disease who may benefit from cardiovascular hemodynamic support beyond the PCI procedure. The trial is a prospective, non-randomized, single-arm, multi-center feasibility study sponsored by Supira Medical. The Supira System is a minimally invasive, percutaneous ventricular assist device designed to provide hemodynamic support during HRPCI. The device's catheter is inserted through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance. It unloads the left ventricle by pumping blood into the ascending aorta and systemic circulation. Patients in the study will undergo this procedure during their HRPCI treatment. Participants will be assessed for safety and feasibility during the perioperative period. Researchers will monitor outcomes such as adverse events related to the procedure and device use, as well as secondary endpoints at 30 days post-procedure. The study includes detailed evaluations of heart function and patient health throughout the process, with the total participation duration spanning from the index procedure through follow-up assessments.
CONDITIONS
Brief 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 the current hospital admission
- Have left ventricular ejection fraction (LVEF) of 45% or less
- Present with unprotected left main coronary artery disease, last patent vessel, 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...
- Stroke within the past 6 months or any prior stroke with permanent neurological deficit
- Moderate or greater aortic valvular disease or regurgitation (2+ or higher on a 4-grade scale on TTE)
- Moderate or greater aortic stenosis or regurgitation (mean gradient >20 mmHg or valve area <1.5 cm2 on TTE)
- Decompensated liver disease or severe liver dysfunction (Child-Pugh Score class C)
- Ongoing dialysis or renal replacement therapy
- Current or past heparin-induced thrombocytopenia
- Known allergy to intravenous contrast agents that cannot be pre-medicated or to heparin, aspirin, ADP receptor inhibitors, or nitinol
- Known or suspected blood clotting disorders or abnormal coagulation parameters
- Pregnant or breastfeeding
- Currently in active follow-up phase of another clinical study of an investigational drug or device
- Other medical, social, or psychological issues that may prevent informed consent or compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo insertion of the Supira System, a minimally invasive ventricular assist device, during the high-risk percutaneous coronary intervention (HRPCI) procedure to provide hemodynamic support.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored to assess safety and feasibility of the Supira System after the HRPCI procedure.
Approximately 6 follow-up visits
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here