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

Inclusion criteria

• Age eligible (18 ≤ Age ≤ 80)
• Subject is indicated for a non-emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft .
• Patient presence at least one of the following a or b:

• Intervention on an unprotected left main coronary artery or intervention on the last patent coronary artery .
• Intervention on patient presenting with three-vessel* disease.

• Three-vessel disease was defined as the presence at least one sign ficant stenosis ≥ 50% in the left anterior descending artery (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, and right coronary artery (RCA) and/or side branch. In the case of left coronary artery dominance, a lesion ≥ 50% in the proximal LAD and the LCX qualified as three-vessel disease.
• Ejection Fraction ≤40% or Coronary rotational atherectomy or According to the assessment of the cardiac team, PCI requires hemodynamic support .
• Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process.

Exclusion criteria

• Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
• Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
• 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])
• Mural thrombus in the left ventricle.
• The presence of aortic valve replacement or mechanical circulatory support device.
• Subject has mechanical complications of myocardial infarction.
• Documented presence of severe aortic stenosis.
• Documented presence of moderate to severe mitral stenosis.
• Documented presence of severe aortic insufficiency.
• Severe peripheral arterial obstructive disease that would preclude device placement.
• Abnormalities of the aorta that would preclude surgery, including aortic aneurysms,aortic dissection and extreme tortuosity or calcifications.
• Subject with renal failure (creatinine ≥265μmol/L)
• Subject with liver dysfunction ( liver enzymes and bilirubin levels ≥3x ULN )
• Subject has uncorrectable abnormal coagulation parameters (platelet count ≤ 75╳109 /L or fibrinogen ≤ 1.50 g/L)
• History of recent (within 1 month) stroke or TIA .
• Severe right ventricular dysfunction,such as severe pulmonary hypertension.
• Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors or contrast media.
• Subject with documented heparin induced thrombocytopenia.
• Subject has pregnant or lactating.
• Participation in the active follow-up phase of another clinical study of an investigational drug or device within 1 month.
• Investigators consider unsuitable to participate in the trial.