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RECRUITING
NCT07407816
NA

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

Sponsor: Supira Medical

View on ClinicalTrials.gov

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

DEVICE

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