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

Prior treatment

• Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
• 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
• 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 HRPCI procedure

Other illness

• Cardiogenic shock or acutely decompensated pre-existing chronic heart failure
• 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

Other

• Left ventricular thrombus
• Breastfeeding or pregnant or planning to become pregnant within 90 days of the HRPCI procedure
• Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures
• Considered to be part of a vulnerable population per the investigator's assessment

• 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