ELEVATE High-Risk PCI Pivotal Study

Eligibility Criteria

• 1. 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).
• 2. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
• 3. Participant signed the informed consent.
• 1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
• 2. Prior stroke with any permanent, significant (mRS\>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
• 3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
• 4. Evidence of left ventricular thrombus.
• 5. Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
• 6. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
• 7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
• 8. Patient on dialysis.
• 9. Known or suspected coagulopathy OR abnormal coagulation parameters.
• 10. Known allergy, sensitivity or intolerance to nickel.
• 11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
• 12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
• 13. Any non-cardiac condition with a life expectancy \< 12 months.
• 14. 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).
• 15. Pregnancy or breast-feeding.
• 16. 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.
• 17. Subject belongs to a vulnerable population.