Study of the Supira System for Heart Failure Patients Undergoing High-Risk Percutaneous Coronary Intervention HRPCI with Support Beyond the Procedure

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 devices 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.

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