ELEVATE High-Risk PCI Pivotal Study

Exclusion Criteria

• •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.