NCT01034371Unknown不适用
Comparison of "One-stop" Hybrid Coronary Revascularization Versus Off-pump Coronary Artery Bypass for the Treatment of Multi-vessel Coronary Artery Disease
China National Center for Cardiovascular Diseases2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2009年12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
- 400
- 试验地点
- 2
- 主要终点
- Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
研究概览
简要总结
The "one-stop" hybrid coronary revascularization combines minimally invasive direct coronary artery bypass (MIDCAB) and PCI to be performed in the hybrid operating suite, an enhanced operating room equipped with radiographic capability. This study is to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with off-pump coronary artery bypass (OPCAB) in selected patients with multivessel coronary artery disease.
详细描述
- With the development of specialized devices and experience, off-pump coronary artery bypass (OPCAB) has been a well-established less invasive technique for coronary revascularization. Compared with conventional on-pump coronary artery bypass grafting (CABG), OPCAB avoids the use of cardiopulmonary bypass and cardioplegic arrest, and is associated with decreased morbidity, shorter length of stay in ICU and hospital, and less perioperative complications, especially in elderly patients with severe comorbidities. "One-stop" (also named simultaneous) hybrid coronary revascularization is also a novel, safe and feasible minimally invasive approach in selected patients with multivessel coronary artery disease (CAD). It allows surgical and interventional procedures to be performed consecutively in the "one-stop" hybrid operating suite, an enhanced operating room equipped with radiographic capability, wherein the left intramammary artery (LIMA) is placed on the left anterior descending artery (LAD) by minimally invasive procedure, immediately followed by percutaneous coronary intervention/stenting on the non-LAD lesions. However, few studies are now available on the outcomes of coronary revascularization between the new hybrid strategy with conventional OPCAB. This study is a single center randomized clinical trial to compare 1-year clinical outcomes of "one-stop" hybrid coronary revascularization with OPCAB in selected patients with multivessel CAD with suitable coronary anatomy.
Sample size:
- We examined the results of SYNTAX trial and of our institution published previously. The 1-year MACCE rate (the primary endpoint) is estimated as being 13% for OPCAB. The sample calculated for this trial is 400 patients.
Design/Methodology:
- Trial design: A single center randomized clinical trial comparing "one-stop" hybrid procedure versus conventional OPCAB in 400 patients with suitable anatomy who need revascularization.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Two- or three-vessel disease, left main disease, or LM equivalent with 2 or 3-vessel disease (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory);
- •LAD diseases not suitable for PCI [i.e. chronic totally occlusion (CTO), severe calcification or/and angulated lesions, bifurcation or trifurcation lesions];
- •Angiographic characteristics of non-LAD lesion(s) amiable to PCI;
- •Chronic stable or unstable angina pectoris of CCS 2 or greater (symptoms of angina and/or objective evidence of myocardial ischemia);
- •Evaluated by both cardiac surgeon and cardiologist together.
排除标准
- •Need for emergent CABG;
- •Prior CABG;
- •Prior PCI with stenting within 6 months of study entry;
- •Stroke with 6 months of study entry;
- •Overt congestive heart failure;
- •Need for a concomitant operation (i.e. valve repair or replacement, Maze surgery);
- •Hemodynamic instability;
- •Situations in which complete revascularization is not possible served;
- •Allergy to radiographic contrast, aspirin or clopidogrel.
- •Contradictions to PCI: Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels <1.5mm; Intolerance to aspirin or both clopidogrel and ticlopidine;
- •Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
- •History of significant bleeding; Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
结局指标
主要结局
Composite of major adverse cardiac or cerebrovascular events (MACCE) including death, myocardial infarction, stroke and/or repeat revascularization.
时间窗: 1 year
次要结局
- Overall MACCE rate.(30 days after procedure and 2 years after enrollment)
- Cardiac death.(30 days after procedure, 1 and 2 years after enrollment)
- Documented myocardial infarction.(30 days after procedure, 1 and 2 years after enrollment)
- Target lesion revascularization.(30 days after procedure, 1 and 2 years after enrollment)
- Recurrence of Angina.(1 and 2 years after enrollment)
- Cost-effectiveness analysis.(1 and 2 years after enrollment)
- Quality of life.(6 months, 1 and 2 years after enrollment)
- Rehospitalization.(6 months, 1 and 2 years after enrollment)
研究者
研究点 (2)
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