NCT00292305已完成4 期
Crush- or Culotte Stenting of Bifurcation Lesions Using Drug Eluting Stents? A Randomized Nordic Multicenter Study (BIF II)
Aarhus University Hospital Skejby2 个研究点 分布在 1 个国家目标入组 425 人开始时间: 2005年9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
- 425
- 试验地点
- 2
- 主要终点
- Combined end point of: cardiac death, myocardial infarction, stent thrombosis or TVR
研究概览
简要总结
This is a study of crush- or culotte stenting of bifurcation lesions using drug eluting stents. This is 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.
Randomization:
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".
- •Diameter of main vessel by visual estimate > 3.0 mm.
- •Diameter of side branch by visual estimate > 2.5 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.
- •Left main bifurcation in a non-right dominant system.
结局指标
主要结局
Combined end point of: cardiac death, myocardial infarction, stent thrombosis or TVR
时间窗: after 6 months
次要结局
- Myocardial infarction(during hospital period; after 1, 6 and 8 months)
- Stent thrombosis(during hospital period; after 1, 6 and 8 months)
- Percentual diameter stenosis of main vessel and side branch(after 8 months)
- Angiographic restenosis (> 50% diameter stenosis) rate of main vessel and side branch(after 8 months)
- Clinical MACE(December 2008)
- TLR(during hospital period; after 1, 6 and 8 months)
- Cardiac death(during hospital period; after 1, 6 and 8 months)
- Total death(during hospital period; after 1, 6 and 8 months)
- Late loss of main vessel and side branch(after 8 months)
- MACE (cardiac death, myocardial infarction, stent thrombosis or TVR)(during hospital period; after 1 and 8 months)
- CCS-angina score(after 6 and 8 months)
- TVR(during hospital period; after 1, 6 and 8 months)
研究者
Evald Hoej Christiansen
MD
Aarhus University Hospital Skejby
研究点 (2)
Loading locations...
相似试验
已完成
4 期
Nordic Bifurcation Study. How to Use Drug Eluting Stents (DES) in Bifurcation Lesions?Coronary Artery DiseaseNCT00376571Aarhus University Hospital Skejby413
已完成
不适用
Bifurcation Lesion Analysis and Stentingatherosclerotic plaquecoronary disease10011082NL-OMON33545Volcano Europe SA/NV15
已完成
4 期
DES Versus BiOSS LIM - POLBOS II StudyCoronary Artery DiseaseNCT02198300Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland202
招募中
不适用
The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte TechniqueCoronary Artery DiseaseNCT05488665Yonsei University512
已完成
不适用
Interventional therapy of bifurcation lesions: A flow-guided concept to treat side branches in bifurcation lesions - a prospective randomized clinical study (THUEringer BIfurcation Study, THUEBIS-Study)ISRCTN22637771Berka Clinic, Department of Cardiology (Zentralklinik Bad Berka, Klinik für Kardiologie) (Germany)110