ELEVATE High-Risk PCI Pivotal Study

The Elevate™ percutaneous Left Ventricular Assist Device System is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease. Use of the Elevate™ System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions.

Inclusion criteria

• Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).
• A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
• Participant signed the informed consent.

Exclusion criteria

• Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
• Prior stroke with any permanent, significant (mRS>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
• Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
• Evidence of left ventricular thrombus.
• Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
• ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
• Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
• Patient on dialysis.
• Known or suspected coagulopathy OR abnormal coagulation parameters.
• Known allergy, sensitivity or intolerance to nickel.
• Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
• Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
• Any non-cardiac condition with a life expectancy < 12 months.
• Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
• Pregnancy or breast-feeding.
• Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures.
• Subject belongs to a vulnerable population.