VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)

Inclusion Criteria: * Subject provides signed informed consent. * Subject is ≥ 18 years and \< 90 years of age. * Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main or Last remaining vessel or Three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories) * Heart team, which must include a cardiac surgeon, agrees that HR-PCI is appropriate. Exclusion Criteria: * Subject has had STEMI within 72 hours with persistent elevation of cardiac enzymes. * Subject has had pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment. * Subject has systolic blood pressure \< 90 mmHg with evidence of end organ hypoperfusion (e.g., cool extremities or urine \< 30 mL/hour). * Subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmHg. * Subject has left ventricular mural thrombus. * Subject has a prosthetic aortic valve. * Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy). * Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, g…