SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI

Exclusion Criteria

• •1. Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
• •2. Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
• •3. Subject is in cardiogenic shock defined as:
• •* CI \< 2.2 L/min/m2 and PCWP \> 15 mmH
• •* Hypotension (systolic BP \< 90 mmHg for \>30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR \[a urine output of \< 30 mL/hour AND a HR \> 60 BPM\])
• •4. Mural thrombus in the left ventricle.
• •5. The presence of aortic valve replacement or mechanical circulatory support device.
• •6. Subject has mechanical complications of myocardial infarction.
• •7. Documented presence of severe aortic stenosis.
• •8. Documented presence of moderate to severe mitral stenosis.
• •9. Documented presence of severe aortic insufficiency.
• •10. Severe peripheral arterial obstructive disease that would preclude device placement.
• •11. Abnormalities of the aorta that would preclude surgery, including aortic aneurysms,aortic dissection and extreme tortuosity or calcifications.
• •12. Subject with renal failure (creatinine ≥265μmol/L)
• •13. Subject with liver dysfunction ( liver enzymes and bilirubin levels ≥3x ULN )
• •14. Subject has uncorrectable abnormal coagulation parameters (platelet count ≤ 75╳109 /L or fibrinogen ≤ 1.50 g/L)
• •15. History of recent (within 1 month) stroke or TIA .
• •16. Severe right ventricular dysfunction,such as severe pulmonary hypertension.
• •17. Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors or contrast media.
• •18. Subject with documented heparin induced thrombocytopenia.
• •19. Subject has pregnant or lactating.
• •20. Participation in the active follow-up phase of another clinical study of an investigational drug or device within 1 month.
• •21. Investigators consider unsuitable to participate in the trial.