Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).

Inclusion Criteria:

- 1. The patient's age is between 18 and 90 years old (inclusive). 2. There is at least one lesion (including primary lesions and restenosis lesions) in the native coronary artery or grafted bypass vessel, and percutaneous coronary intervention (PCI) needs to be performed under hemodynamic support.

3. The patient meets one of the following conditions:

1. The left ventricular ejection fraction (LVEF) is <=35%, and the vessel to be treated with interventional therapy is an unprotected left main coronary artery lesion or a lesion with only a single remaining open vessel.
2. The left ventricular ejection fraction (LVEF) is <=30%, and the vessel to be treated with interventional therapy is a three-vessel coronary artery lesion.

Among them, a three-vessel coronary artery lesion is defined as follows: there is at least one significant stenosis in each of the three main epicardial coronary arteries (the left anterior descending branch and/or its branches, the left circumflex branch and/or its branches, the right coronary artery and/or its branches). A significant stenosis is defined as a luminal stenosis >= 50% (by visual inspection) or complete occlusion, and at least two vessels have a luminal stenosis >= 70%. For left-dominant coronary arteries, the presence of >= 50% stenosis in both the left anterior descending branch and the proximal left circumflex branch is also regarded as a three-vessel coronary artery lesion.

4. The subject or his/her legal guardian is able to understand the purpose of the trial, voluntarily participates in the trial and signs the informed consent form, and is willing to complete the follow-up as required by the trial.

Exclusion Criteria:

• 1. Acute ST-segment elevation myocardial infarction within 24 hours before enrollment.

  2. Cardiac arrest occurred within 24 hours before enrollment and cardiopulmonary resuscitation was required.

  3. Emergency thrombolysis was performed before enrollment. 4. Cardiogenic shock exists, and cardiogenic shock is defined as follows: (1) Cardiac index (CI) < 2.2 L/min/m² and pulmonary capillary wedge pressure (PCWP) > 15 mmHg; (2) Hypotensive state (systolic blood pressure < 90 mmHg for more than 30 minutes, or systolic blood pressure maintained >= 90 mmHg with the support of vasoactive drugs and/or circulatory assist devices), accompanied by end-organ hypoperfusion (urine output < 30 ml/hour and heart rate > 60 beats/minute, or cold and clammy extremities).

  5. Left ventricular mural thrombus exists. 6. After aortic valve replacement (including mechanical valves, biological valves), implantation of mechanical circulatory assist devices or cardiac contractile devices.

  7. Moderate or severe aortic stenosis, moderate or severe aortic insufficiency. 8. Severe peripheral arterial stenosis or occlusion lesions that interfere with the implantation of the test device or the control device.

  9. Aortic lesions (including aortic aneurysms, aortic dissections, extreme tortuosity or calcification) that interfere with the operation.

  10. Chronic renal insufficiency (serum creatinine >= 4 mg/dl), or dialysis treatment is required.

  11. Liver insufficiency (liver transaminase and bilirubin levels are more than 3 times the upper limit of the normal range).

  12. Uncorrected abnormal coagulation function (platelet count <= 75,000/mm³ or INR >= 2.0 or fibrinogen <= 1.5 g/L).

  13. A history of stroke or transient ischemic attack (TIA) within 1 month before enrollment.

  14. Allergic or intolerant to iodine contrast agents, heparin, aspirin, ADP receptor inhibitors, and with a history of heparin-induced thrombocytopenia (HIT) in the past.

  15. Infectious endocarditis exists or is suspected to exist, or there is a systemic active infection.

  16. Currently participating in other drug/device clinical trials and the primary endpoint has not been reached.

  17. Pregnant or lactating women, those with a fertility plan within 1 year or those who are unwilling to take effective contraceptive measures.

  18. Other situations judged by the investigator as not suitable for enrollment that are unforeseen.