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.
Patient age ≥18 years old;
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;
Cardiac arrest within 24 hours;
The implantation of an interventional left ventricular assist system was either contraindicated or not feasible;
ST-segment elevation myocardial infarction (STEMI) within 24 hours;
Chronic Kidney Disease;
Parallel
VentriCure Interventional left ventricular assist system
DeviceThe VentriCure interventional left ventricular assist system provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention.
ECMO
DeviceSubjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure.
Incidence of major adverse events at 30 days post-PCI
Major adverse events were defined as follows: death, new myocardial infarction, stroke, target-vessel revascularization, major bleeding. Calculation formula: 30-day MAE rate = Number of subjects experiencing any MAE event within 30 days post-PCI ÷ Total number of subjects × 100%
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