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
Parallel
The Supira System
DeviceThe Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent HRPCI performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option.
Impella
DeviceThe current commercially available Impella CP with SmartAssist Catheter is indicated for providing temporary (≤ 6 hours) ventricular support during elective or urgent high risk percutaneous coronary i
Composite Safety and Efficacy Outcomes
* All-cause death * Myocardial infarction * Stroke or transient ischemic attack * Major bleeding * Major access site-related vascular complications * Acute Kidney Injury * Unplanned repeat revascularization * Sustained hypotensiona during mechanical circulatory support * Arrythmia requiring cardioversion during pump use
Secondary Outcome Measures
Individual rates of the following outcomes: * All-cause death * MI * Stroke or TIA * Major bleeding * Major access site-related vascular complications * AKI * Unplanned repeat vascularization * Cardiovascular re-hospitalization * Ventricular arrhythmia requiring cardioversion * Major cardiac structural complications * Major Hemolysis
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