Assessment of Neointimal Stent Strut Coverage and Endothelial Function After Second Generation Drug-Eluting Stent Systems
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To compare coronary endothelial function after primary angioplasty.
研究概览
简要总结
The purpose of this study is to compare coronary endothelium function in patients with a zotarolimus-eluting versus a sirolimus-eluting or a everolimus-eluting stents with optical coherence tomography, vasoconstriction in response to acetylcholine, and coronary biomarker level.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant coronary de novo lesion (> 70% by quantitative angiographic analysis)
- •Patients with stable or acute coronary syndrome considered for coronary revascularization
- •Reference vessel diameter of 2.5 to 3.5 mm by operator assessment
排除标准
- •Contraindication to anti-platelet agents
- •Ostial lesion within 5 mm from ostium
- •Different DES in other vessel simultaneously
- •Creatinine level 2.5 mg/dL
- •Left main stenosis more than 50%.
- •vein graft lesion
- •Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
- •Life expectancy 1 year
- •Reference vessel < 2.5 mm or > 4.0 mm diameter by visual
- •Long lesion that require more than three stents
研究组 & 干预措施
zotarolimus-eluting stents (ENDEAVOR®)
干预措施: zotarolimus-eluting stent (ENDEAVOR®) (Device)
sirolimus-eluting stents (CYPHER SELECT® PLUS)
干预措施: sirolimus-eluting stents (CYPHER SELECT® PLUS) (Device)
everolimus-eluting stents (PROMUS®)
干预措施: everolimus-eluting stents (PROMUS®) (Device)
结局指标
主要结局
To compare coronary endothelial function after primary angioplasty.
时间窗: 6 months and 12 months
To compare the presence of neointimal stent strut coverage via optical coherence tomography.
时间窗: 6 months and 12 months
To compare the serum biomarker levels measured in coronary artery blood.
时间窗: 6 months and 12 months
次要结局
未报告次要终点
研究者
Kenichi Fujii
Assistant Professor
Hyogo Medical University