Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Ongoing renal replacement therapy with dialysis * Presence of decompensated liver disease; severe liver dysfunction * Infection of the proposed procedural access site or active infection * Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol * Any condition, coagulopathy, planned procedure or contraindication that requires discontinuation of antiplatelet and/or anticoagulant therapy within 90 days of the index procedure * Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure * Currently participating in active follow-up phase of another clinical study of an investigational drug or device or planning to enroll in such a study within 90 days of the H…