Temporary Mechanical Circulatory Support With the iVAC 2L Transaortic Device in High-risk Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes. Mechanical circulatory support (MCS) devices may offer hemodynamic stabilization during PCI, potentially improving short- and long-term outcomes. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention.
The transaortic system for short-term circulatory support with pulsatile blood flow iVAC 2L consists of an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) with a patented two-way rotary valve.
The pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole.
The primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.
详细描述
Although coronary artery bypass grafting (CABG) remains the standard treatment for patients with multivessel coronary artery disease, there is growing interest in performing protected percutaneous coronary intervention (PCI) in high-risk patients. Protected PCI involves the use of temporary mechanical circulatory support (MCS) devices during and shortly after the procedure to maintain hemodynamic stability and reduce the risk of complications such as acute left ventricular failure. This approach offers a safer alternative to open-heart surgery in patients for whom CABG poses significant operative risks. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention.
On admission patients will undergo ECG, echocardiography, routine blood tests including complete blood count and basic metabolic panel. After then the patient's risk will be assessed by the institution's heart team (presence of severe coronary artery disease, acute coronary syndrome, other comorbidities including renal disease, diabetes mellitus, chronic and acute heart failure etc.).
For placement of the iVAC 2L transaortic device the patient will be transported to the X-ray operating room. The transaortic system for short-term circulatory support with pulsatile blood flow that consists of three main components: an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) and a patented two-way rotary valve. The pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole. Advantages of the iVAC 2L include a minimally invasive implantation technique, pulsatile flow that may be more physiologic compared to continuous flow devices, and a lower risk of hemolysis and vascular complications compared to other MCS devices.
After surgery further monitoring of the patient will be carried out in the intensive care unit. During hospitalization treatment and diagnostic evaluation of patients will be done according to current clinical practice guidelines.
The primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multidisciplinary heart team consensus for high-risk PCI. HR-PCI was defined as any percutaneous intervention for coronary disease involving an unusually high risk of periprocedural circulatory collapse.
- •Signed Informed Consent to participate in the study
排除标准
- •Femoral artery diameter < 6.0mm
- •Significant biventricular or right heart failure
- •Thrombus in the left ventricle
- •Presence of a mechanical aortic valve
- •Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less) or moderate-to-severe aortic insufficiency (echocardiographic assessment graded as ≥+2)
- •Severe peripheral arterial disease precluding placement of the iVAC2L
- •Combined cardiorespiratory failure
- •Presence of an atrial or ventricular septal defect (including post infarct VSD)
- •Left ventricular rupture
- •Cardiac tamponade
- •Presence of any other subtype of shock
- •Known severe comorbidities independently affecting prognosis (chronic renal or liver failure, active malignancies etc.)
- •Recent major bleeding event (< 3 months)
- •Recent stroke (< 3 months)
结局指标
主要结局
All-cause mortality
时间窗: At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.
Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG).
次要结局
- Major vascular complications(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.)
- Angiographic failure(Immediately after PCI.)
- Incidence of intraprocedural complications(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.)
- Left ventricular myocardial function(At day 7 after PCI or at discharge, if earlier.)
- Severity of mitral valve regurgitation(At baseline (before the PCI).)
- Angiographic characteristics(From the beginning of the PCI until its conclusion. The PCI is estimated to be from 40 to 270 minutes.)
- Number of Participants with ventricular arrhythmias(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.)
- Number of participants with progression of cardiogenic shock(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.)
- Repeat revascularization(At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.)
- Intraprocedual device-related characteristics(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.)
- Change in Left ventricular ejection fraction(From baseline (before the PCI) to the moment of discharge, typically on the 5-7 day after PCI.)
- Severity of aortic valve regurgitation(At baseline (before the PCI).)
- Severity of mitral valve stenosis(At baseline (before the PCI).)
- Severity of triscupid valve regurgitation(At baseline (before the PCI).)
- Severity of aortic valve stenosis(At baseline (before the PCI).)
- Major vascular complications(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.)
- Left ventricular myocardial function(At day 7 after PCI or at discharge, if earlier.)
- Number of Participants with ventricular arrhythmias(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.)
- Number of participants with major bleeding(At day 7 after PCI or at discharge, if earlier.)
- Angiographic failure(Immediately after PCI.)
- Incidence of intraprocedural complications(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.)
- Repeat revascularization(At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.)
- Intraprocedual device-related characteristics(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes.)
- Severity of mitral valve regurgitation(At baseline (before the PCI).)
- Incidence of recurrent myocardial infarction or reinfarction(During the 360-day follow-up period)
- Incidence of acute kidney injury(At day 7 after PCI or at discharge, if earlier.)
- Angiographic characteristics(From the beginning of the PCI until its conclusion. The PCI is estimated to be from 40 to 270 minutes.)
- Number of participants with progression of cardiogenic shock(From the beginning of the PCI until its conclusion, the PCI is estimated to be from 40 to 270 minutes. At day 7 after PCI or at discharge, if earlier.)
- Number of participants with acute myocardial infarction(At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.)
- Number of participants with stroke or transient ischemic attack(At day 7 after PCI or at discharge, if earlier. At day 360 of follow-up.)
- Change in Left ventricular ejection fraction(From baseline (before the PCI) to the moment of discharge, typically on the 5-7 day after PCI.)
- Severity of aortic valve regurgitation(At baseline (before the PCI).)
- Severity of mitral valve stenosis(At baseline (before the PCI).)
- Severity of triscupid valve regurgitation(At baseline (before the PCI).)
- Severity of aortic valve stenosis(At baseline (before the PCI).)
研究者
Dmitry Pevzner
Head of the Emergency Cardiology Department
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation