Feasibility Study SA of the Supira System for HRPCI

Inclusion Criteria: Age ≥ 18 and ≤ 90 years Will undergo elective or urgent HRPCI, where hemodynamic support is needed, as determined by the institutional Heart Team Signed the informed consent Exclusion Criteria: ST-elevation myocardial infarction (STEMI) within 30 days Stroke within 3 months of the index procedure, or prior stroke > 3 months with any permanent neurologic deficit Evidence of left ventricular thrombus Previous aortic valve replacement or reconstruction Ascending or descending aortic dissection or aortic aneurysm > 4.5 cm Previous transcatheter mitral valve replacement or repair Ventricular septal defect Aortic and iliofemoral anatomical conditions that preclude safe delivery and placement of the device Mechanical ventilation due to primary respiratory mechanical dysfunction (e.g., pneumonia, ARDS, pneumothorax) Breastfeeding or pregnant Currently participating in active follow-up phase of another clinical study of an investigational drug or device Active COVID-related infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments Considered to be part of a vulnerable population Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous INR ≥ 1.5 or known fibrinogen ≤ 1.5 g/L)