NCT00914199已完成不适用
Stenting of Coronary Artery Stenoses With Significant Side Branches. Should we, or Should we Not, Perform Dilatation of the Side Branch Through the Main Vessel Stent, if There is Acceptable Blood Flow in the Side Branch?
Evald Hoej Christiansen2 个研究点 分布在 1 个国家目标入组 477 人开始时间: 2007年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 477
- 试验地点
- 2
- 主要终点
- Combined end point of: cardiac death, index lesion myocardial infarction, stent thrombosis or target lesion revascularisation
研究概览
简要总结
Should we, or should we not, perform dilatation of the side branch through the main vessel stent, if there is acceptable blood flow in the side branch?
详细描述
Design:
- Randomised open multicentre trial
Patients:
- Number 477
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable or unstable angina pectoris. -Bifurcation lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA--
- •PDA/posterola¬te¬ral branch" or "LM/Cx/LAD".
- •Diameter of main vessel by visual estimate > 2.5 mm.
- •Diameter of side branch by visual estimate > 2.25 mm.
- •Signed informed consent
排除标准
- •Age < 18 years.
- •ST-elevation infarction within 24 hours.
- •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 end point of: cardiac death, index lesion myocardial infarction, stent thrombosis or target lesion revascularisation
时间窗: After 6 months
次要结局
- Cardiac death(during hospital period, after 1, 8 and 14 months, 2 and 3 years)
- Stent thrombosis(during hospital period, after 1, 8 and 14 months, 2 and 3 years)
- CCS angina score(after 1, 8 and 14 months, 2 and 3 years)
- MACE (cardiac death, myocardial infarction, stent thrombosis or target vessel revascularisation)(during hospital period, after 1, 8, and 14 months, 2 and 3 years)
- Myocardial infarction(related to the index procedure)
- Target vessel revascularisation(during hospital period, after 1, 8 and 14 months, 2 and 3 years)
- Total mortality(during hospital period, after 1, 6, 8 and 14 months, 2 and 3 years)
- Target lesion revascularisation(during hospital period, after 1, 8 and 14 months, 2 and 3 years)
- Angiographic significant stenosis (>50%) of main vessel and/or occlusion of the side branch(after 8 months)
- Late loss of main vessel and side branch(after 8 months)
- Angiographic significant stenosis (>50%) of main vessel(after 8 months)
- Angiographic significant stenosis (>50%) of main vessel and/or side branch(after 8 months)
- Angiographic significant stenosis (>50%) of side branch(after 8 months)
- Markers(before and after the procedure)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby
研究点 (2)
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