CorVad Percutaneous Ventricular Assist System Study

Exclusion Criteria

• •1\. ST-segment elevation myocardial infarction (STEMI) on ECG within 7 days;
• •2\. Cardiac arrest requiring cardiopulmonary resuscitation within 24 hours pre-procedure;
• •3\. Cardiogenic shock defined as meeting all of the following:
• •1. Systolic blood pressure \<90mmHg, or requiring vasopressors/inotropes to maintain blood pressure \>90mmHg;
• •2. Clinical evidence of end-organ hypoperfusion (cold extremities or urine output \<30ml/h), or use of IABP or other mechanical circulatory assist device;
• •3. Cardiac index (CI) \<2.2L/min/m\^2 and pulmonary capillary wedge pressure (PCWP) \>15mmHg;
• •4\. Presence of left ventricular thrombus;
• •5\. Presence of mechanical aortic valve or cardiac contractility device;
• •6\. Presence of moderate-to-severe aortic valve stenosis;
• •7\. Presence of moderate-to-severe aortic valve insufficiency;
• •8\. Deemed unable to tolerate percutaneous ventricular assist device based on clinical or imaging assessment, including iliac/femoral artery diameter \<6mm, severe tortuosity, severe bilateral iliofemoral/femoral artery disease, or other peripheral vascular disease;
• •9\. Presence of aortic vascular disease or aortic dissection;
• •10\. Presence of uncorrected, sustained ventricular arrhythmia causing inability to stable position percutaneous ventricular assist device;
• •11\. History of stroke with permanent neurological deficit, intracerebral hemorrhage, subdural hematoma, or conditions predisposing to intracranial hemorrhage such as arteriovenous malformation or mass;
• •12\. End-stage renal disease requiring dialysis or serum creatinine ≥4mg/dL;
• •13\. Presence of potential bleeding diathesis or hypercoagulable state;
• •14\. Pregnancy (for women of childbearing potential, pregnancy test required within 7 days prior to PCI procedure);
• •15\. Presence of contraindication to anticoagulation;
• •16\. History of liver failure, with ALT, AST, and bilirubin elevated to 3 times the upper limit of normal (ULN) or international normalized ratio (INR) ≥2;
• •17\. Presence of uncorrected abnormal coagulation parameters (platelet count ≤75,000/mm\^3, INR≥2.0, or fibrinogen ≤1.50g/L);
• •18\. Presence of uncontrolled active infection requiring antibiotic therapy;
• •19\. Participation in any other clinical trial that may impact the results of this study;
• •20\. Other circumstances that are unforeseen and determined by the investigator to be unsuitable for the study.