NCT06357026尚未招募不适用
The Safety and Efficacy of the Percutaneous Left Ventricular Assist System for Intraoperative Circulatory Support During High-risk Percutaneous Coronary Intervention (PCI): a Prospective, Multi-center, Randomized Controlled Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 344
- 试验地点
- 8
- 主要终点
- Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
研究概览
简要总结
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old≤ patient age ≤90 years old AND patient is not in pregnancy or lactation;
- •Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
- •Left Ventricular Ejection Fraction (LVEF) ≤ 35% AND at least one of the following criteria:
- •Intervention on the last patent coronary conduit, or
- •Intervention on an unprotected left main coronary artery Or b) LVEF ≤ 30% and intervention in patient presenting with triple vessel disease.
- •Patient who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
排除标准
- •Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR;
- •Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment;
- •Patient is in cardiogenic shock;
- •Mural thrombus in the left ventricle;
- •Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects;
- •The presence of mechanical aortic or mitral valve or heart constrictive device;
- •The presence of aortic stenosis (aortic orifice area ≤1.5cm²)；
- •The presence of moderate to severe aortic or mitral or tricuspid insufficiency;
- •The presence of severe peripheral vascular disease that would preclude the placement of the percutaneous mechanical circulatory assist device;
- •Severe aortic diseases such as aortic dissection and aortic aneurysm;
- •Active infective endocarditis or other active infections;
- •Chronic renal insufficiency (creatinine clearance≤30ml/min);
- •Liver dysfunction (elevation of liver enzymes and bilirubin levels to ≥3xULN or INR≥2);
- •The presence of uncorrectable abnormal coagulation (platelet count≤75,000/mm^3 or INR≥2.0 or fibrinogen≤1.50 g/l);
- •The presence of uncorrected moderate to severe anemia (hemoglobin <90 g/L);
- •History of stroke or TIA within 1 month of enrolment;
- •Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.);
- •Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research;
- •Patient with poor compliance and could not complete the study as required determined by the investigator.
结局指标
主要结局
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
时间窗: 30 days after procedure
MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.
次要结局
- Incidence of acute kidney injury(30 days, 90 days after procedure)
- Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion(30 days, 90 days after procedure)
- Incidence of myocardial infarction(30 days, 90 days after procedure)
- Incidence of death(30 days, 90 days after procedure)
- Incidence of stroke(30 days, 90 days after procedure)
- Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia(30 days, 90 days after procedure)
- Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)(90 days after procedure)
- Incidence of target vessel revascularization(30 days, 90 days after procedure)
- Incidence of increasing in aortic insufficiency by more than one grade(30 days, 90 days after procedure)
- Incidence of severe hypotension(30 days, 90 days after procedure)
- Evaluation of Experimental device performance(Immediately after procedure)
- Incidence of failure to achieve angiographic success(30 days, 90 days after procedure)
- Procedural success rate(Immediately after procedure)
- Hemodynamic support success rate during PCI procedure(During procedure)
- Technical success rate(Immediately after procedure)
- Change in LVEF compared to baseline(30 days, 90 days after procedure)
- Improvement in cardiac function(30 days, 90 days after procedure)
研究者
研究点 (8)
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