Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 286
- 试验地点
- 15
- 主要终点
- 30-day Major Adverse Events (MAE) rate
研究概览
简要总结
Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years.
In China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement.
Common pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients.
The aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for 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
- •1. Aged 18-90
- •The investigator assesses that the subject requires coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is considered high-risk or the subject refuses CABG. The investigator believes the subject may benefit from PCI (Percutaneous Coronary Intervention).
- •3. Left ventricular ejection fraction (LVEF) ≤ 35%.
- •Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions:
- •Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).
- •A last remaining patent coronary artery (the anterior descending artery (LAD) and/or its branches, the circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches).
- •Saphenous vein graft (SVG) vascular lesions.
- •Severely calcification, tortuosity.
- •Multivessel disease (two or more) combined with chronic total occlusion (CTO).
- •Three-vessel disease. Three-vessel disease is defined as significant stenosis (≥ 70%) in at least one segment of all three major epicardial coronary artery territories: the left anterior descending artery (LAD) and/or its branches, the left circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches. In a left-dominant coronary system, lesions in the proximal segments of the LAD and LCX are also considered three-vessel disease.
- •5. Patients who are able to give informed consent and complete the follow-up.
排除标准
- •Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP <90 mmHg for ≥30 min or requiring supportive measures to maintain SBP >90 mmHg and end-organ hypoperfusion (urine output <30 ml/h or cool extremities).
- •STEMI or CK-MB did not return to the normal range within 24 hours.
- •Cardiac arrest with cardiopulmonary resuscitation within 24 hours.
- •Left ventricular mural thrombus.
- •After aortic valve replacement surgery (mechanical, bioprosthetic).
- •Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.
- •Moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency.
- •Atrial septal or ventricular septal defects (including post-infarction VSD), or post-myocardial infarction Free-Wall Rupture, or papillary muscle rupture.
- •Severe right heart failure or severe tricuspid valve insufficiency.
- •Disease or abnormality of the aorta that interferes with the procedure, including Marfan syndrome, coarctation of aortic, aortic aneurysm, severe tortuosity or calcification of the aorta.
- •Severe peripheral arterial stenosis or occlusive lesions.
- •Uncorrectable moderate or severe anemia prior to the procedure (hemoglobin <90 g/L). Abnormal coagulation function (routine blood test indicates platelet count less than 75×109/L, INR ≥2.0, or fibrinogen ≤1.5 g/L).
- •Known contraindications to heparin, contrast agents, or study-required medications (e.g., aspirin, clopidogrel); history of Heparin-induced thrombocytopenia.
- •Active hemorrhage within 1 month.
- •History of stroke or TIA or permanent neurologic deficits within one month prior to the procedure.
- •Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L) within 7 days.
- •Liver dysfunction: liver AST, ALT and bilirubin >3 times the upper limit of normal within 7 days.
- •Presence or suspected presence of infective endocarditis or systemic infection.
- •Women who are pregnant, breastfeeding, or planning pregnancy during the trial.
- •Participation in another drug or medical device clinical trial.
- •Other conditions deemed by the investigator as unsuitable for participation in this trial.
研究组 & 干预措施
VADLINK
The VADLINK percutaneous left ventricular assist system will offer intraoperative hemodynamic support during high-risk PCI procedures.
干预措施: Implantation of the VADLINK Percutaneous Left Ventricular Assist Device (Device)
V-A ECMO
The VA-ECMO offers intraoperative hemodynamic support during high-risk PCI procedures.
干预措施: VA-ECMO (Device)
结局指标
主要结局
30-day Major Adverse Events (MAE) rate
时间窗: From enrollment to 30 ±7 days after PCI surgery
Occurrence of a major adverse event (MAE) up to 30 days post-implantation. Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, Unplanned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation or ventricular arrhythmias after electrical cardioversion.
30-day Major Adverse Events (MAE) rate
时间窗: From enrollment to 30 ±7 days after PCI surgery
Occurrence of a major adverse event (MAE) up to 30 days post-implantation. Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, Unplanned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation or ventricular arrhythmias after electrical cardioversion.
次要结局
- Incidence of adverse events(Implant up through 90 days)
- Serious adverse event incidence rate(Implant up through 90 days)
- Incidence of device defects(Periprocedural)
- The MACCE rate(30, 90 days)
- Mean units transfused(30 days)
- Incidence of hemodynamic instability(30 days)
- 90-day Major Adverse Events (MAE) rate(90 days)
- Incidence of device-related adverse events(Implant up through 90 days)
- Incidence of device-related serious adverse events(Implant up through 90 days)
- The MACCE rate(30, 90 days)
- Transfusion rate(30 days)
- Mean units transfused(30 days)
- Incidence of hemodynamic instability(30 days)
- 90-day Major Adverse Events (MAE) rate(90 days)
- Incidence of device-related adverse events(Implant up through 90 days)
- Incidence of device-related serious adverse events(Implant up through 90 days)
- Incidence of adverse events(Implant up through 90 days)
- Serious adverse event incidence rate(Implant up through 90 days)
- Incidence of device defects(Periprocedural)