New heart pump could help High-Risk patients during angioplasty

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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