NCT07675005尚未招募不适用
The Prospective, Multicenter, Randomized Controlled Clinical Trials Comparing the VentriCure Left Ventricular Assist System With ECMO for Supporting High-risk PCI Procedures
Life Shield Medical Technology Co., LTD0 个研究点目标入组 220 人开始时间: 2026年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Incidence of major adverse events at 30 days post-PCI
研究概览
简要总结
This study aims to evaluate the safety and effectiveness of the VentriCure interventional left ventricular assist system for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multi-center, randomized controlled clinical trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥18 years old;
- •As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG;
- •The patient is meeting one of the following:
- •(1) Coronary Artery Disease and left ventricular ejection fraction ≤35%; (2) Coronary Artery Disease and left ventricular ejection fraction ≤40% and severe heart failure;
- •PCI was required for imaging diagnosis;
- •Patient willing and able to comply with protocol requirements and accept clinical follow-up; able to understand study purpose and sign informed consent.
排除标准
- •Cardiac arrest within 24 hours;
- •The implantation of an interventional left ventricular assist system was either contraindicated or not feasible;
- •ST-segment elevation myocardial infarction (STEMI) within 24 hours;
- •Chronic Kidney Disease;
- •Severe right heart failure or severe tricuspid regurgitation;
- •Presence of abnormal coagulation parameters (platelet count ≤75,000/mm^3, INR≥2.0, or fibrinogen ≤1.50g/L);
- •Moderate or higher anemia;
- •History of stroke or transient ischemic attack (TIA) within one month;
- •Allergy or intolerance to anticoagulants or contrast agent;
- •Active internal bleeding within a month;
- •Presence of uncontrolled active infection;
- •Pregnant or lactating women;
- •Patients are participating in other clinical trials;
- •Other circumstances that are determined by the investigator to be unsuitable for the study.
结局指标
主要结局
Incidence of major adverse events at 30 days post-PCI
时间窗: 30 days post-PCI
Major adverse events were defined as follows: death, new myocardial infarction, stroke, target-vessel revascularization, major bleeding. Calculation formula: 30-day MAE rate = Number of subjects experiencing any MAE event within 30 days post-PCI ÷ Total number of subjects × 100%
次要结局
未报告次要终点
研究者
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