NCT02226900Unknown不适用
Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease
InCor Heart Institute2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of Revascularization Procedure Proposed by the Heart Team
研究概览
简要总结
This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization OR triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
- •Total SYNTAX score > 22
- •LCx and RCA territories estimated to be equivalently revascularized by either PCI or CABG, with at least one major non-LAD vessel to be treated
- •Clinical and anatomic eligibility for both PCI and CABG as agreed to by both interventional and surgical consensus
- •Interventionalist determines PCI appropriateness and eligibility
- •Surgeon determines surgical appropriateness and eligibility
- •Silent ischemia, stable angina, unstable angina or recent MI
- •If recent MI, cardiac biomarkers must have returned to normal prior to randomization
- •Ability to sign informed consent and comply with all study procedures
排除标准
- •Prior PCI or CABG at any time prior to randomization
- •Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
- •Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
- •Patients requiring additional surgery (cardiac or non cardiac) within one year
- •The presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented)
- •The presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by CABG, but rather should be managed with PCI. or medical therapy - reasons will be documented)
- •Non cardiac co-morbidities with life expectancy less than 1 year
- •Other investigational drug or device studies that have not reached their primary endpoint.
结局指标
主要结局
Feasibility of Revascularization Procedure Proposed by the Heart Team
时间窗: 30 days
The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.
次要结局
- Stent Thrombosis(1 year)
- Bleeding(1 year)
- Safety(1 year)
- Medication Impact(1 year)
- Efficacy of the Strategy(1 year)
- Symptomatic Graft Occlusion(1 Year)
- Recurrence of Angina(1 year)
- Neurological Events(1 year)
- Major Adverse Cardiovascular Events(180 days)
- Graft Patency(1 year)
- Clinical and Angiographic Scores Correlation with Prognostic(1 year)
研究者
Pedro A. Lemos
Pedro A. Lemos, Professor of Medicine, InCor Heart Institute
InCor Heart Institute
研究点 (2)
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