Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
brief summary
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI. Eligible patients will be randomized to undergo HRPCI with either the Supira System (investigational device) or the commercially available Impella systems (comparator device).
detailed description
The Supira System is a minimally invasive percutaneous ventricular assist device (pVAD) that is intended to provide temporary hemodynamic support (≤ 4 hours) to patients undergoing HRPCI. The Supira Catheter is inserted percutaneously through the femoral artery, across the aortic valve, and into the left ventricle under fluoroscopic guidance, with the pump outlet remaining in the ascending aorta. The pump portion of the Catheter compresses during insertion in the Introducer Sheath and re-expands during use. It actively unloads the left ventricle by pumping blood from the ventricle into the ascending aorta and systemic circulation.
official title
Pivotal Randomized Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)