DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 776
- 试验地点
- 1
- 主要终点
- percentage of neointimal coverage at 3 month-OCT after stent implantation
研究概览
简要总结
The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES vs BES implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 20 years old
- •Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation.
- •Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm
- •Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
排除标准
- •Complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
- •Reference vessel diameter < 2.5 mm or > 4.0mm
- •Heavy calcified lesions (definite calcified lesions on angiogram)
- •Primary PCI for STEMI
- •Contraindication to anti-platelet agents
- •Treated with any DES within 3 months at other vessel
- •Creatinine level ≥ 2.0 mg/dL or ESRD
- •Severe hepatic dysfunction (3 times normal reference values)
- •Pregnant women or women with potential childbearing
- •Life expectancy < 1 year
研究组 & 干预措施
Angio guided PCI
干预措施: Angio-guided PCI with EES or BES (Device)
OCT-guided PCI
干预措施: OCT-guided PCI with EES or BES (Device)
BES
干预措施: PCI with BES under angio-guide or OCT guide (Device)
EES
干预措施: PCI with EES under angio-guide or OCT guide (Device)
Keep dual antiplatelet therapy (DAPT)
Study subjects will be allocated into this arm with non-randomization method
干预措施: Keep DAPT (Drug)
Discontinue Dual antiplatelet therapy (DAPT)
Study subjects will be allocated into this arm with non-randomization method
干预措施: Discontinue DAPT (Drug)
结局指标
主要结局
percentage of neointimal coverage at 3 month-OCT after stent implantation
时间窗: at 3 month-OCT after stent implantation
次要结局
- The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 months(12 months after PCI)
- percentage of malposition strut at 3 month-OCT after stent implantation(3 months after PCI)
- The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke.(12 months after PCI)
- Target vessel revascularization(12 months after PCI)
- TIMI-defined major bleeding for 12 months(12 months after PCI)