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

Ki vehet részt

• Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%
• Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease
• Subject may benefit from hemodynamic support beyond the index procedure
• Informed consent granted by the patient or legally authorized representative

Ki nem vehet részt

• Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
• Ongoing renal replacement therapy with dialysis or continues renal replacement therapy
• Heparin-induced thrombocytopenia, current or any prior occurrences
• Currently participating in active follow-up phase of another clinical study of an investigational drug or device
• Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
• Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)
• 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)
• 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)
• Breastfeeding or pregnant
• 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