The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus extracorporeal membrane oxygenation (ECMO) for circulatory support during high-risk PCI.
This prospective, multi-center, randomized controlled clinical trial of the Percutaneous Ventricular Assist System is designed to measure the incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
250
Percutaneous Ventricular Assist System provides intraoperative circulatory support during high-risk PCI.
ECMO provides intraoperative circulatory support during high-risk PCI.
The Second Hospital of Jilin University
Jilin City, Changchun, China
West China Hospital, Sichuan University
Chengdu, Chengdu, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.
Time frame: 30 days after procedure
Incidence of death
Rate of all-cause death during the trial.
Time frame: 30 days, 90 days after procedure
Incidence of myocardial infarction
Rate of patients with myocardial infarction during the trial.
Time frame: 30 days, 90 days after procedure
Incidence of stroke
Rate of patients with stroke during the trial.
Time frame: 30 days, 90 days after procedure
Incidence of target vessel revascularization
Rate of patients with target vessel revascularization during the trial.
Time frame: 30 days, 90 days after procedure
Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia
Rate of patients with unplanned cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia during the trial.
Time frame: 30 days, 90 days after procedure
Incidence of acute kidney injury Remove
Rate of patients with acute kidney injury during the trial.
Time frame: 30 days, 90 days after procedure
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion
Rate of patients with cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion during the trial.
Time frame: 30 days, 90 days after procedure
Incidence of increasing in aortic insufficiency by more than one grade
Rate of patients with increasing in aortic insufficiency by more than one grade during the trial.
Time frame: 30 days, 90 days after procedure
Incidence of severe hypotension
Rate of patients with severe hypotension during the trial. Severe hypotension defined as systolic blood pressure or augmented diastolic pressure (whichever is greater) \<90 mmHg for ≥5 min requiring inotropic/pressor medications or IV fluid.
Time frame: 30 days, 90 days after procedure
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
Rate of patients with freedom from major adverse cardiovascular and cerebrovascular events (MACCE) during the trial. MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.
Time frame: 90 days after procedure
Hemodynamic support success rate during PCI procedure
Hemodynamic support success is defined as (1) Percutaneous mechanical circulatory assist device was delivered and activated successfully, and withdrawn from the body successfully; (2) Hemodynamic stability during procedure (defined as mean arterial pressure (MAP) \<60mmHg for no more than 10 minutes during the PCI procedure and additional pressor medication is not required).
Time frame: During procedure
Technical success rate
Technical success is defined as (1) Hemodynamic support success; (2) Coronary revascularization success (defined as ①residual stenosis \<30% after coronary stent implantation; ②restoration of TIMI anterograde flow of II or III).
Time frame: mmediately after procedure
Procedural success rate
Procedure success is defined as (1) Technical success; (2) Freedom from serious in-hospital procedural complications
Time frame: Immediately after procedure
Change in LVEF compared to baseline
LVEF is assessed at 30 days, 90 days after procedure, and compared to baseline
Time frame: 30 days, 90 days after procedure
Improvement in cardiac function
Cardiac function is evaluated based on NYHA classification and compared to baseline. New York Heart Association (NYHA) Functional Classification includes four categories(CLASS I to CLASS IV, higher class mean a worse outcome) based on physical activity limitations.
Time frame: 30 days, 90 days after procedure
Evaluation of Experimental device performance
Performance evaluation includes the catheter pump and extracorporeal control device (For each assessment: 1-10 points;1=worst, 5=moderate, 10=best).
Time frame: Immediately after procedure