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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
The PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP).
The 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.
Time frame: 30 days post-operation
Incidence of major adverse events within 90 days post-operation.
Time frame: 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 .
Time frame: 30 days post-operation
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 .
Time frame: 90 days post-operation
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)
Time frame: 90 days post-operation
The success rate of percutaneous coronary intervention(PCI)
The success rate of PCI is defined as: residual stenosis \< 30% after stent implantation or \< 50% after balloon angioplasty, or thrombolysis in myocardial infarction(TIMI) flow grade 3.
Time frame: 90 days post-operation
Complete revascularization rate
Complete revascularization rate is defined as: residual SYNTAX score ≤8
Time frame: Immediately after the intervention
Change in creatinine clearance
Time frame: Baseline to 48 hours postoperation and 30 days post-operation
The change in left ventricular ejection fraction (LVEF) compared to baseline
Time frame: Baseline to 30 days post-operation and 90 days post-operation
The change in New York heart association(NYHA) classification compared to baseline
The NYHA classification of heart function consists of four levels, ranging from I to IV, with heart function progressively deteriorating.
Time frame: 30 days post-operation, 90 days post-operation
Length of hospital stay within 30 days post-operation
Time frame: 30 days post-operation
Length of intensive care unit(ICU)/(coronary care unit)CCU stay within 30 days post-operation
Time frame: 30 days post-operation
Success rate of device operation
The system has delivered to the designated position and completed the pump start-up without any device failure.
Time frame: 30 days post-operation
Usage time of research device
The time from the start to the stop of the research device.
Time frame: 30 days post-operation
Device performance evaluation
The operator scores the device after use, with 5 being the best and 1 being the worst.
Time frame: Intraoperation
The failure rate of the device
The failure rate of the device is defined as any component of the research equipment (Ventiflow LP or ECMO) system that is unable to operate according to its designed performance specifications .
Time frame: Intraoperation
Incidence of serious adverse events
Incidence of serious adverse events: Serious adverse events refer to those that occur during the clinical trial process and result in death or a significant deterioration in health status, including fatal diseases or injuries, permanent impairment of bodily structure or function, and events that require medical or surgical intervention to prevent permanent impairment of bodily structure or function, among others.
Time frame: 90 days post-operation
The incidence of serious adverse events
The incidence of serious adverse events related to medical devices: including but not limited to cardiac structural damage, severe limb ischemia (pallor, pulselessness, and necrosis), infections, damage to the aorta and aortic valve, hemolysis, complications requiring surgical intervention, and events leading to subject mortality, permanent or severe disability, significantly prolonged hospitalization, or the need for surgical intervention .
Time frame: 90 days post-operation
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