About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- VentriCure Interventional left ventricular assist system
- ECMO