Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients

Inclusion Criteria: 1. Non-emergent, percutaneous coronary intervention is planned in at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis) 2. Ejection fraction of ≤ 45% and at least one of the following: 1. Intervention on an unprotected left main coronary artery 2. Intervention on a last patent coronary conduit 3. Three-vessel disease (in case of left coronary artery dominance, the combination of a Left Anterior Descending Artery (LAD) lesion and a proximal Left Circumflex Artery (LCX) lesion qualifies as three-vessel disease) 3. Femoral artery diameter compatible with the use of Elevate™ 4. Subject signed informed consent Exclusion Criteria: 1. Subject age \< 40 or ≥ 83 years 2. Cardiogenic shock 3. Left ventricular mural thrombus 4. Presence of a mechanical aortic valve or a heart-constrictive device 5. Aortic stenosis 6. Moderate or severe aortic regurgitation (≥ 2+ by Transthoracic Echocardiography) 7. Severe peripheral vascular disease 8. Aortic pathology, such as aortic aneurysms, extreme tortuosity or calcifications that could pose an undue additional risk to the placement of a pLVAD device 9. Chronic renal dysfunction (serum creatinine ≥ 3.5 mg/dL) 10. Uncorrectable abnormal coagulation parameters (defined as platelet count ≤ 75,000 or INR ≥ 2.0 or fibrinogen ≤ 1.5 g/L) 11. Active systemic infection 12. Stroke or transient ischemic attack within 3 months of enrollment 13. Female subjects who are pregnant or breast-feeding