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).
Hemodynamically stable and will undergo elective or urgent (not emergent) HRPCI, where hemodynamic support is deemed necessary, as determined by the institutional Heart Team
Informed consent granted by the subject or legally authorized representative
Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
Left ventricular thrombus
Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the investigational device or the comparator device