The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System

The Prospective, Multicenter, Randomized Controlled Clinical Trials Comparing the VentriCure Left Ventricular Assist System With ECMO for Supporting High-risk PCI Procedures

This study aims to evaluate the safety and effectiveness of the VentriCure interventional left ventricular assist system for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multi-center, randomized controlled clinical trial.

Inclusion Criteria:

1. Patient age ≥18 years old;
2. As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG;
3. The patient is meeting one of the following:

(1) Coronary Artery Disease and left ventricular ejection fraction ≤35%; (2) Coronary Artery Disease and left ventricular ejection fraction ≤40% and severe heart failure; 4. PCI was required for imaging diagnosis; 5. Patient willing and able to comply with protocol requirements and accept clinical follow-up; able to understand study purpose and sign informed consent.

Exclusion Criteria:

1. Cardiac arrest within 24 hours;
2. The implantation of an interventional left ventricular assist system was either contraindicated or not feasible;
3. ST-segment elevation myocardial infarction (STEMI) within 24 hours;
4. Chronic Kidney Disease;
5. Severe right heart failure or severe tricuspid regurgitation;
6. Presence of abnormal coagulation parameters (platelet count ≤75,000/mm^3, INR≥2.0, or fibrinogen ≤1.50g/L);
7. Moderate or higher anemia;
8. History of stroke or transient ischemic attack (TIA) within one month;
9. Allergy or intolerance to anticoagulants or contrast agent;
10. Active internal bleeding within a month;
11. Presence of uncontrolled active infection;
12. Pregnant or lactating women;
13. Patients are participating in other clinical trials;
14. Other circumstances that are determined by the investigator to be unsuitable for the study.