NCT00376571已完成4 期
Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions? A Strategy of Routine Stenting Both Main Vessel and Side Branch Versus a Strategy of Routine Main Vessel Stenting and Optional Treatment of Side Branch
Aarhus University Hospital Skejby2 个研究点 分布在 1 个国家目标入组 413 人开始时间: 2004年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 413
- 试验地点
- 2
- 主要终点
- Combined end-point of cardiac death, MI, stent thrombosis or TVR.
研究概览
简要总结
How to use drug eluting stents (DES) in bifurcation lesions. A strategy of routine stenting of both main vessel and side branch versus a strategy of routine main vessel stenting and optional treatment of side branch. A randomized Nordic multicenter study including 400 patients with angina pectoris with clinical angiographic follow-up.
详细描述
Design:
* Randomized open multicentre trial.
Patients:
- Number 400.
Inclusion criteria:
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 AP.
- •Bifurcation lesion of "LAD/diagonal", "Cx/obtuse marginal", "RCA-PDA/posterolateral branch or LM/Cx/LAD in a right dominant system.
- •Diameter of main vessel by visual estimate > 2.5 mm.
- •Diameter of side branch by visual estimate > 2.0 mm.
- •Signed informed consent.
排除标准
- •ST-elevation AMI within 24 hours.
- •Expected survival < 1 year.
- •S-creatinine > 200 Umol/l.
- •Allergy to Aspirin, Clopidogrel or Ticlopidine.
- •Allergy to sirolimus/paclitaxel.
- •Left main bifurcation in a non-right dominant system.
结局指标
主要结局
Combined end-point of cardiac death, MI, stent thrombosis or TVR.
时间窗: After 6 months
次要结局
- Clinical: MACE (cardiac death, MI, stent thrombosis or TVR) during hospital period, after 1 and 8 months. Cardiac death, myocardial infarction, stent thrombosis, TVR, total death, TLR during hospital period, after 1, 6 and 8 months. Myocardial infarction(During hospital period, after 1, 6 and months.)
- Angiographic: Restenosis of the main vessel and/or occlusion of the side branch. Late loss of main vessel and side branch after 8 months. Angiographic restenosis (>50% diameter stenosis) rate of main vessel and side branch after 8 months.(After 8 months)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby
研究点 (2)
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