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Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
Sponsor: Supira Medical
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2025-10-12
Completion Date
2027-05
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Supira 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