Micro-axial Flow Pump-Supported PCI Plus Optimal Medical Therapy Versus Optimal Medical Therapy Alone in Complex Coronary Artery Disease With Ischemic LV Dysfunction: A Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 452
- 试验地点
- 1
- 主要终点
- 1-year MACCE
研究概览
简要总结
Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump） for patients with complex coronary heart disease (CHD) complicated by ischemic left ventricular systolic dysfunction. Through a prospective, multi-center, open-label 1:1 randomized controlled trial, a total of 452 patients with severe ischemic systolic dysfunction and complex coronary lesions were enrolled. The study compared the 12-month incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) between patients who received interventional therapy supported by the CorVad percutaneous left ventricular assist system in addition to the most appropriate medical therapy and those who only received the most appropriate medical therapy. This was done to test whether the interventional therapy supported by the CorVad percutaneous left ventricular assist system can improve the prognosis of patients with severe ischemic systolic dysfunction and complex coronary lesions.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is aged ≥18 years;
- •The subject has been diagnosed with chronic or acute coronary syndrome and has a left ventricular ejection fraction <35%;
- •After comprehensive evaluation by the cardiac team, it is considered that the subject may benefit from PCI treatment;
- •The subject has signed an informed consent form approved by the ethics committee, has good compliance after discharge, and is willing to undergo clinical follow-up.
- •At least two vascular occlusive lesions (with the diameter of the occluded vessel >2.5mm) or unprotected left main coronary artery disease, and meeting one or more complex procedural criteria, or three-vessel disease, and meeting two or more complex procedural criteria;
排除标准
- •Received mechanical circulatory assistance devices (including IABP, ECMO, Impella, etc.) before randomization;
- •Acute myocardial infarction within 7 days or undergoing thrombolytic therapy;
- •Combined with aortic dissection, pulmonary embolism, or severe pulmonary hypertension;
- •Patients with cardiogenic shock or hemodynamic instability;
- •Cardiopulmonary resuscitation was performed before randomization;
- •Mechanical complications (including ventricular perforation, interventricular septal perforation, mitral valve chordae rupture, etc.) confirmed before randomization and subsequent to acute myocardial infarction;
- •The mechanical circulatory assist device cannot be implanted or there are contraindications (including but not limited to left ventricular mural thrombus, artificial aortic valve or cardiac contractile device, moderate or severe aortic stenosis, moderate or severe aortic regurgitation, presence of stents in peripheral vascular access, tortuosity, dissection, and other severe vascular lesions that hinder the implantation of the investigational device, aortic aneurysm or severe malformation abnormalities, blood cell fragility or hemolytic blood system diseases, hypertrophic or hypertrophic obstructive cardiomyopathy, etc.);
- •Severe abnormalities in platelets, with a count below 50×10^9/L or above 600×10^9/L;
- •Active visceral hemorrhage or hemorrhagic stroke occurs within 1 month;
- •Unable to use antiplatelet or anticoagulant drugs;
- •Has a history of drug allergy and cannot tolerate conventional cardiovascular drug therapy and intraoperative medications;
- •Severe renal insufficiency, requiring or expected to require long-term dialysis treatment;
- •Severe active infection, puncture site infection, sepsis, or septicemia;
- •Life expectancy is less than or equal to 1 year;
- •Women who are pregnant or breastfeeding;
- •Severe right heart failure or severe tricuspid regurgitation;
- •Participation in other clinical trials has not yet reached the primary endpoint;
- •Other situations that are unforeseen or deemed unsuitable by the researcher's comprehensive judgment.
结局指标
主要结局
1-year MACCE
时间窗: Up to 1 year after enrollment
a composite endpoint consisting of cardiovascular death, spontaneous myocardial infarction, non-fatal stroke, ischemia-driven revascularization, and readmission for heart failure
次要结局
- Perioperative myocardial infarction(Up to 48h after the index PCI procedure)
- Types 3, 4, and 5 bleeding as defined by MCS-ARC(Up to 1 year after enrollment)
- Severe hemolysis related to the device(Up to 72 hours after the implantation of the CorVad left ventricular assist system)
- Stent thrombosis(Up to 1 year after the index PCI procedure)