Evidence of an acute myocardial infarction ≤ 30 days before enrollment.
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure.
Blood dyscrasias as defined: leukopenia (WBC < 3000 cell/mL, anemia (Hgb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), history of bleeding diathesis or coagulopathy.
Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization.
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days.
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment.
Need for emergency surgery for any reason.
Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 25% as measured by resting echocardiogram.
Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment.
Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy, or end stage renal disease requiring chronic dialysis.
GI bleeding within the past 3 months.
Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen.
History of cirrhosis or any active liver disease.
Significant abdominal or thoracic aortic disease (such as porcelain aorta, abdominal aortic aneurysm > 5.0 cm, severe calcification, aortic coarctation, etc.) that would preclude safe passage of the delivery system.
Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, ticlopidine and clopidogrel, contrast media, nickel, cobalt ,chromium, titanium, molybdenum, rhenium, polyethylene materials.
Ongoing sepsis, including active endocarditis.
BMI > 50 kg/m2.
Subject refuses a blood transfusion.
Life expectancy < 12 months due to associated non-cardiac co-morbid conditions.
Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
Currently participating in an investigational drug or another investigational device trial.
Subject is contraindicated for cardiac CT.
Subject belongs to a vulnerable population (Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention).