The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.
18 Years to 90 Years
The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI
The subject is diagnosed with acute or chronic coronary syndrome, and
LVEF≤ 35% or
Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;
Cardiopulmonary resuscitation within 24 hours;
Patients who have had cardiogenic shock (systolic blood pressure < 90 mmHg for more than 30 minutes or need catecholamines to maintain systolic blood pressure above 90 mmHg) or hemodynamic instability within 7 days before surgery;
Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;
Parallel
Percutaneous left ventricular assist device(Ventiflow LP)
DeviceThe PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP).
VA-ECMO
DeviceThe PCI will be completed with the support of Veno-arterial extracorporeal membrane oxygenation (VA-ECMO).
Incidence of major adverse events within 30 days post-operation.
Major adverse events are defined as death, stroke, myocardial infarction, revascularization, rehospitalization due to cardiovascular reasons, bleeding types 3, 4, 5 defined by mechanical circulatory support academic research consortium (MCS-ARC) , acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation.
Incidence of major adverse events within 90 days post-operation.
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-operation.
MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures .
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-operation.
MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures .
Success rate of hemodynamic support during device use
definition of successful hemodynamic support: successful delivery and initiation of the device, no hemodynamic deregulation occurs during the device support period (haemodynamic derangement refers to: mean arterial pressure(MAP ) less than 60 mmHg for more than 10 minutes and requires additional vasoactive drug therapy)
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