CorVad Percutaneous Ventricular Assist System Study

Inclusion Criteria:

• 1. 18 years old≤ patient age ≤90 years old;
• 2. Patient willing and able to comply with protocol requirements and data collectionprocedures; able to understand study purpose and sign informed consent;
• 3. As assessed by the cardiac team the patient needs coronary revascularization, butCABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses toundergo CABG. After comprehensive evaluation, the cardiac team believes that thepatient can benefit from PCI (Percutaneous Coronary Intervention);
• 4. The patient is hemodynamically stable and meeting one of the following:

1. Left ventricular ejection fraction (LVEF) ≤30%, with multivessel disease,planning PCI to at least one complex lesion* in a major epicardial vessel orbranch;
2. LVEF ≤35% and either: I. Unprotected left main intervention; II. Or last patent coronary conduit;
3. LVEF ≤40%, planning PCI to at least one complex lesion* in a major epicardialvessel or branch. The intervention team confirms there is a risk of cardiacarrest or circulatory collapse. This must be confirmed by at least two associatesenior physicians or one chief senior physician.

• Complex lesions include moderate-to-severe calcification, chronic totalocclusions (CTO), diffuse disease, bifurcation lesions, severe tortuosity,etc.

Exclusion Criteria:

• 1. ST-segment elevation myocardial infarction (STEMI) on ECG within 7 days;
• 2. Cardiac arrest requiring cardiopulmonary resuscitation within 24 hourspre-procedure;
• 3. Cardiogenic shock defined as meeting all of the following:

1. Systolic blood pressure <90mmHg, or requiring vasopressors/inotropes to maintainblood 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 clinicalor imaging assessment, including iliac/femoral artery diameter <6mm, severetortuosity, severe bilateral iliofemoral/femoral artery disease, or other peripheralvascular disease;
• 9. Presence of aortic vascular disease or aortic dissection;
• 10. Presence of uncorrected, sustained ventricular arrhythmia causing inability tostable position percutaneous ventricular assist device;
• 11. History of stroke with permanent neurological deficit, intracerebral hemorrhage,subdural hematoma, or conditions predisposing to intracranial hemorrhage such asarteriovenous 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 7days prior to PCI procedure);
• 15. Presence of contraindication to anticoagulation;
• 16. History of liver failure, with ALT, AST, and bilirubin elevated to 3 times theupper 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 thisstudy;
• 20. Other circumstances that are unforeseen and determined by the investigator to beunsuitable for the study.