Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 932
- 试验地点
- 9
- 主要终点
- 2-year composite end points
研究概览
简要总结
The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent.
Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated.
Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics.
However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments.
The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.
详细描述
The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.
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
- •patients who need multi-vessel stenting with multi-vessel disease
- •patients with signed informed consent
排除标准
- •known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group
- •Cardiogenic shock
- •Pregnant women or women with potential childbearing
- •End-stage diseases with life expectancy shorter than 2 years
- •patients with other Drug eluting stents implanted
- •Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.
结局指标
主要结局
2-year composite end points
时间窗: up to 2 years
All cause death, non fatal myocardial infarction, any revascularization
次要结局
- Any revascularization(up to 2 years)
- non fatal myocardial infarction(up to 2 years)
- cardiac death(up to 2 years)
- Target lesion revascularization(up to 2 years)
- Target vessel revascularization(up to 2 years)
- stent thrombosis(up to 2 years)
- All cause death(up to 2 years)
- non-cardiac death(up to 2 years)
研究者
NAM, Chang-Wook
Associate Professor of Internal Medicine
Keimyung University Dongsan Medical Center