Single-arm Trial Evaluating the Effectiveness of PCI of de Novo 3-vessel Disease Applying the SYNTAX Score II With Pressure Wire Functional Assessment and IVUS Guidance, Using an Everolimus-eluting Stent With Biodegradable Abluminal Coating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 454
- 试验地点
- 22
- 主要终点
- Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
研究概览
简要总结
Clinical study that aims to evaluate a new strategy using the SYNTAX II Score calculator in the functional assessment of patients with new coronary 3-vessel-disease who undergo percutaneous coronary intervention (PCI)
详细描述
The purpose of the SYNTAX II Trial is to investigate the management of de-novo 3-vessel-disease in order to prospectively assess which patients would have at least comparable short and long term clinical outcomes between coronary artery bypass graft and percutaneous coronary intervention (PCI), using contemporary PCI practice. In SYNTAX II the effectiveness of a contemporary stent (designed with thinner struts, biocompatible and biodegradable polymer, and a limus based drug), the use of pressure wire assessment of lesions to allow for ischemia-driven revascularisation, intravascular ultrasound (IVUS) guidance to optimise drug eluting stent deployment, and the treatment of (chronic) total occlusion lesions with contemporary techniques, will be compared against PCI practice in the original SYNTAX trial. The proposed study would involve the SYNTAX Score II to prospectively recruit subjects on the grounds of patient safety
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 1 stenosis, angiographic, visually determined de novo lesions with more than 50 percent diameter stenosis in all 3 major epicardial territories. These are left descending coronary artery (LAD) and or side branch, proximal circumflex coronary artery (LCX) and or side branch, right descending coronary artery (RCA) and or side branch which are supplying viable myocardium without left main involvement. Patients with ostial LAD or ostial CX Medina 0,0,1 or Medina 0,1,0 may be enrolled
- •Patients with hypoplastic RCA with absence of descending posterior and presence of a lesion in the LAD and CX territories may be included in the trial as a 3 vessel disease equivalent
- •Vessel size should be at least 1.5 mm in diameter as visually assessed in diagnostic angiogram
- •Patients with
- •stable (Canadian Cardiovascular Society Class 1, 2, 3 or 4) angina pectoris
- •or unstable (Braunwald class) angina pectoris and ischemia
- •or patients with atypical chest pain or those who are asymptomatic provided they have myocardial ischemia, for example treadmill exercise test, radionuclide scintigraphy, stress echocardiography
- •All anatomical SYNTAX Scores are eligible for initial screening with the SYNTAX Score II
- •Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site
- •Signed Heart Team Decision Form between local cardiologist and surgeon that the selected case meets all of the inclusion and exclusion criteria
排除标准
- •Under the age of 21 years
- •Known pregnancy at time of enrolment. Female of childbearing potential, and last menstruation within the last 12 months, who are not taking adequate contraceptives. Female who is breastfeeding at time of enrolment
- •Prior PCI or CABG
- •Ongoing acute myocardial infarction and enzymes (CKMB) more than 2x upper limit of normal
- •Concomitant cardiac valve disease requiring surgical therapy, reconstruction or replacement
- •Single or two-vessel disease at time of Heart Team consensus
- •Participation or planned participation in another cardiovascular clinical study before one year follow up is completed
- •Mental condition, psychiatric or organ cerebral disease, rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent and potential for non-compliance towards the requirement in the study protocol
结局指标
主要结局
Umber of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
时间窗: 1 year
MACCE is defined as: all-cause death; cerebrovascular event (stroke); documented myocardial infarction or all-cause revascularization
次要结局
- Number of Participants With All-cause Death, Stroke, or Myocardial Infarction(1 Year)
- Number of Participants With All-cause Death(1 Year)
- Number of Participants With Probable Stent Thrombosis(1 year)
- Number of Participants With Stroke(1 Year)
- Number of Participants With Revascularization(1 Years)
- Number of Participants With Myocardial Infarction(1 year)
- Number of Participants With Definite Stent Thrombosis(1 Year)