Interventional Ventricular Assist System for PCI in Complicated and High-risk Patient: a Prospective, Multicenter, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Major adverse event
研究概览
简要总结
In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge. These high-risk patients pose an extreme surgical risk. However, with the development of new interventional techniques and materials, PCI is a good alternative to CABG and is referred to as complex high-risk indicated PCI (CHIP).
During CHIP, hemodynamics can deteriorate because of temporary complete coronary occlusion or profound myocardial ischemia. This could result in loss of cardiac output and hemodynamics collapse. Mechanical support during CHIP facilitates native cardiac function by achieving a stable hemodynamic state to withstand repetitive derangements such as ischemia caused by prolonged and repeated balloon inflations, and resume original cardiac function immediately postprocedure or shortly thereafter.
There are several mechanical circulatory support (MCS) systems available, i.e., intra-aortic balloon counterpulsation (IABP), Impella, TandemHeart, and veno-arterial extracorporeal membrane oxygenation (VA-ECMO). These MCS have been widely studied in patients with acute myocardial infarction (MI) complicated by cardiogenic shock and showed conflicting results. However, studies regarding the use of MCS in the setting of CHIP are much less abundant and no randomized study has compared Impella with VA-ECMO in CHIP patients.
The aim of the study is to evaluate the effectiveness of interventional ventricular assist system (CorVad) compared to the venoarterial extracorporeal membrane oxygenation (VA-ECMO) system 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
- Single (Outcomes Assessor)
盲法说明
A blinded and independent clinical event adjudication committee will adjudicate all primary and secondary outcomes
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 to 90 Years
- •The Heart Team determined that the patients required coronary artery revascularization, but there is a high risk of CABG or the patients refuses CABG. After evaluation by the Heart Team, it was concluded that the patients can benefit from revascularization by undergoing high risk PCI
- •The subject is diagnosed with acute or chronic coronary syndrome, and
- •LVEF≤ 35% or
- •LVEF ≤ 40% and NYHA Classification is III or IV
- •Patients who are able to give informed consent and complete the follow-up
- •Image inclusion criteria
- •At least two vessel chronic total occlusions (CTOs) (diameter of occluded artery ≥ 2.5mm)
- •Unprotected left main coronary artery disease, and meeting one or more complex PCI maneuver criteria
- •Three-vessel disease and meeting two or more complex PCI criteria
- •Complex PCI maneuvers are defined as:
- •Bifurcation require the treatment of both branches (including stents or PTCA)
- •Calcification require Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy
- •Severe tortuosity
- •Target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 points)
排除标准
- •Had mechanical circulatory support treatment (such as IABP, ECMO, pVAD) before randomization
- •Acute myocardial infarction or with thrombolytic treatment within 7 days
- •Cardiopulmonary resuscitation within 24 hours
- •Cardiogenic shock (systolic blood pressure < 90 mmHg for more than 30 minutes or requiring vasoactive drugs to maintain systolic blood pressure above 90 mmHg) or hemodynamically unstable
- •pVAD and ECMO cannot be inserted or contraindicated (including but not limited to left ventricular mural thrombus, artificial aortic valve or cardiac contraction device, moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency, peripheral stents, tortuosity, dissection and other severe vascular diseases obstructing the insertion of the study device, aortic dissection, aneurysm or severe abnormalities of the ascending aorta and/or aortic arch, red blood cell fragility or blood disorders, hypertrophic obstructive cardiomyopathy)
- •Abnormal coagulation function (routine blood test indicates platelet count less than 50×109/L, or more than 700×109/L)
- •Active visceral bleeding occurred within 1 month
- •Ischemic or hemorrhagic stroke occurred within 1 month
- •Known contraindication to antiplatelet and anticoagulant medications
- •Known contraindication to medications such as Heparin or contrast.
- •Need for dialysis treatment
- •Active infection
- •Expected life span of less than one year
- •Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice)
- •Currently participating in another trial and not yet at its primary endpoint
- •Severe pulmonary arterial hypertension
- •Severe right heart failure or severe tricuspid regurgitation
- •Unforeseen circumstances that the researcher has deemed to be inappropriate
研究组 & 干预措施
Microaxial flow pump
The microaxial flow pump (The CorVad percutaneous ventricular assist system) will offer intraoperative hemodynamic support during high-risk PCI procedures.
干预措施: Microaxial flow pump (Device)
VA-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
Major adverse event
时间窗: 1 month
Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, revascularization, cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation
次要结局
- All-cause death(1, 3, 12, 24, 36, and 60 months)
- Stroke(1, 3, 12, 24, 36, and 60 months)
- Myocardial infarction(1, 3, 12, 24, 36, and 60 months)
- Revascularization(1, 3, 12, 24, 36, and 60 months)
- Cardiovascular hospitalization(1, 3, 12, 24, 36, and 60 months)
- MCS-ARC defined type 3, 4, 5 bleeding(1 month)
- Acute kidney injury(1 month)
- Serious device-related adverse events(1 month)
- Cardiopulmonary resuscitation(1 month)
- Hospitalization time(1 month)
- Intensive care unit (ICU/CCU) stay time(1 month)
- ECMO/Corvad utilization time(1 month)
- Hemodynamic disorder(1 month)
- Transfusion rate(1 month)
- Units of transfusion(1 month)
- Major adverse event(3, 12, 24, 36, and 60 months)
- Major Adverse Cardiovascular and Cerebrovascular Events(1, 3, 12, 24, 36, and 60 months)