Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure

Exclusion Criteria11

• Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
• Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
• Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient \>20 mmHg or valve area \<1.5 cm2 as assessed on TTE)
• Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)
• Ongoing renal replacement therapy with dialysis or continues renal replacement therapy
• Heparin-induced thrombocytopenia, current or any prior occurrences
• 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
• Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥1.5 in the absence of medication or known fibrinogen ≤1.5 g/L)
• Breastfeeding or pregnant
• Currently participating in active follow-up phase of another clinical study of an investigational drug or device
• 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