NCT06198998招募中不适用
The Prospective, Multi-center, Single-arm Clinical Evaluation Trial of the CorVad Percutaneous Ventricular Assist System
Shenzhen Core Medical Technology CO.,LTD.12 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年10月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.
研究概览
简要总结
This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous 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, multicenter, single-arm clinical trial.
详细描述
This prospective, multicentre, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI and is planned to enrol 120 subjects.
The target population of subjects are patients with coronary artery disease who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 30 days after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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;
- •Patient willing and able to comply with protocol requirements and data collection procedures; able to understand study purpose and sign informed consent;
- •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. After comprehensive evaluation, the cardiac team believes that the patient can benefit from PCI (Percutaneous Coronary Intervention);
- •The patient is hemodynamically stable and meeting one of the following:
- •Left ventricular ejection fraction (LVEF) ≤30%, with multivessel disease, planning PCI to at least one complex lesion* in a major epicardial vessel or branch;
- •LVEF ≤35% and either:
- •I. Unprotected left main intervention;
- •II. Or last patent coronary conduit;
- •LVEF ≤40%, planning PCI to at least one complex lesion* in a major epicardial vessel or branch. The intervention team confirms there is a risk of cardiac arrest or circulatory collapse. This must be confirmed by at least two associate senior physicians or one chief senior physician.
- •Complex lesions include moderate-to-severe calcification, chronic total occlusions (CTO), diffuse disease, bifurcation lesions, severe tortuosity, etc.
排除标准
- •ST-segment elevation myocardial infarction (STEMI) on ECG within 7 days;
- •Cardiac arrest requiring cardiopulmonary resuscitation within 24 hours pre-procedure;
- •Cardiogenic shock defined as meeting all of the following:
- •Systolic blood pressure <90mmHg, or requiring vasopressors/inotropes to maintain blood pressure >90mmHg;
- •Clinical evidence of end-organ hypoperfusion (cold extremities or urine output <30ml/h), or use of IABP or other mechanical circulatory assist device;
- •Cardiac index (CI) <2.2L/min/m^2 and pulmonary capillary wedge pressure (PCWP) >15mmHg;
- •Presence of left ventricular thrombus;
- •Presence of mechanical aortic valve or cardiac contractility device;
- •Presence of moderate-to-severe aortic valve stenosis;
- •Presence of moderate-to-severe aortic valve insufficiency;
- •Deemed unable to tolerate percutaneous ventricular assist device based on clinical or imaging assessment, including iliac/femoral artery diameter <6mm, severe tortuosity, severe bilateral iliofemoral/femoral artery disease, or other peripheral vascular disease;
- •Presence of aortic vascular disease or aortic dissection;
- •Presence of uncorrected, sustained ventricular arrhythmia causing inability to stable position percutaneous ventricular assist device;
- •History of stroke with permanent neurological deficit, intracerebral hemorrhage, subdural hematoma, or conditions predisposing to intracranial hemorrhage such as arteriovenous malformation or mass;
- •End-stage renal disease requiring dialysis or serum creatinine ≥4mg/dL;
- •Presence of potential bleeding diathesis or hypercoagulable state;
- •Pregnancy (for women of childbearing potential, pregnancy test required within 7 days prior to PCI procedure);
- •Presence of contraindication to anticoagulation;
- •History of liver failure, with ALT, AST, and bilirubin elevated to 3 times the upper limit of normal (ULN) or international normalized ratio (INR) ≥2;
- •Presence of uncorrected abnormal coagulation parameters (platelet count ≤75,000/mm^3, INR≥2.0, or fibrinogen ≤1.50g/L);
- •Presence of uncontrolled active infection requiring antibiotic therapy;
- •Participation in any other clinical trial that may impact the results of this study;
- •Other circumstances that are unforeseen and determined by the investigator to be unsuitable for the study.
结局指标
主要结局
Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-PCI.
时间窗: 30 days post-PCI
Major adverse events were defined as follows: death, new myocardial infarction, stroke, and target vessel revascularisation. Calculation formula: 30-day MACCE rate = Number of subjects experiencing any MACCE event within 30 days post-PCI ÷ Total number of subjects × 100%
次要结局
- Change in creatinine clearance at 48 hours post-PCI(Pre-procedure and 48 hours post-PCI)
- Change in New York Heart Association (NYHA) functional classification(Pre-procedure and post-PCI)
- Combined incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-PCI.(90 days post-PCI)
- Hemodynamic stability during PCI procedure(During PCI procedure)
- PCI procedural angiographic success rate(Post-PCI)
- Change of aortic valve regurgitation(Pre-procedure and pre-discharge)
- Change in left ventricular ejection fraction (LVEF) pre- and post-PCI(Pre-procedure, 48 hours post-PCI and pre-discharge)
研究者
研究点 (12)
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