NCT01496638进行中（未招募）不适用
How Should Coronary Artery Stenoses With Significant Side Branch be Stented? A Strategy of Stenting Both Main Vessel and Side Branch Compared to a Strategy of Stenting the Main Vessel and Only Stenting the Side Branch if Necessary.
Evald Hoej Christiansen2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2008年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation
研究概览
简要总结
How should coronary artery stenoses with significant side branch be stented?
A strategy of stenting both main vessel and side branch compared to a strategy of stenting the main vessel and only stenting the side branch if necessary.
The 2-stent strategy is superior to the 1-stent strategy regarding occurrence of cardiac death, non-procedure related myocardial infarction and re-revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
详细描述
Design:
- Randomised open multicentre trial.
Patients:
- Number 450.
Randomisation:
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
- •Stable or unstable angina pectoris or silent angina pectoris.
- •Genuine bifurcation lesion ( Medina type 1,1,1 or 1,0,1 or 0,1,1)
- •Lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA-PDA/posterolateral branch" or "LM/Cx/LAD".
- •Diameter of main vessel by visual estimate >3.0 mm.
- •Diameter of side branch by visual estimate >2.75 mm.
- •Signed informed consent.
排除标准
- •ST-elevation infarction within 24 hours.
- •Side branch lesion length >15 mm.
- •Expected survival < 1 year.
- •S-creatinine >200 µmol/l.
- •Allergy to Aspirin, Clopidogrel or Ticlopidine.
- •Allergy to Sirolimus.
结局指标
主要结局
Combined endpoint of: Cardiac death, non-index procedure related myocardial infarction or target lesion revascularisation
时间窗: After 6 months
次要结局
- MACE (cardiac death, non-index procedure related myocardial infarction, stent thrombosis or target lesion revasculation)(During admission, after 1, 24, 36 and 60 months.)
- Non-index procedure related myocardial infarction during the admission.(After 1, 6, 24, 36 and 60 months.)
- Stent thrombosis.(During admission, after 1, 6, 24, 36 and 60 months.)
- target lesion revascularisation.(During admission, after 1, 6, 24, 36 and 60 months.)
- Index procedure related myocardial infarction based on biomarkers (CK-MB mass, TNT/TNI(During hospital period, 1, 8, 24, 36 and 60 months)
- Total mortality(During admission, after 1, 6, 24, 36 and 60 months and 10 years.)
- CCS angina class(After 6, 8, 24, 36 and 60 months.)
- Cardiac death.(During the admission, after 1, 6, 24, 36 and 60 months.)
- target vessel revascularisation.(During admission, after 1, 6, 24, 36 and 60 months.)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby
研究点 (2)
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