NCT01035567已完成2 期
Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease
Silesian Centre for Heart Diseases4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding.
研究概览
简要总结
The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.
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
- 否
入选标准
- •Age 18 or more
- •Angiographically confirmed multivessel CAD with involved LAD and critical (>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG
- •Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia
- •Patient is willing to comply with all follow-up visits
- •Patient signed an Informed Consent
排除标准
- •Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment
- •Prior surgery with the opening of pericardium or pleura
- •Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects
- •Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation
- •One or more chronic total occlusions in major coronary territories
- •Left main stenosis (at least 50% diameter stenosis)
- •Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization
- •Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
- •Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition
- •Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
- •Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
- •Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease
- •Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age
- •Concurrent enrollment in another clinical trial
- •Patient inaccessible for follow-up visits required by protocol
结局指标
主要结局
Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding.
时间窗: 1 year
次要结局
- Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2(1 year)
- Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments(1 year)
- Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.(1 year)
研究者
Marian Zembala
MD, PhD, Head of the Cardiosurgery and Transplantology Department
Silesian Centre for Heart Diseases
研究点 (4)
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