Serial EValuation of multiplE Coronary Artery Diseases by an Optical Coherence Tomography; Assessment of the Changes of de Novo Lesions and Comparisons of Neointimal Coverage Between Xience Prime® Versus Cypher SelectTM Stents; SEVEN-Xience Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- neointimal coverage according to the implanted DES; Xience vs. Cypher
研究概览
简要总结
This study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted DES and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by OCT. In addition, the investigators will compare the changes such as plaques and neointimal coverage from serial OCT follow-up according to the different statin strategy.
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
- •Patient is ≥ 20 years old
- •Patients with typical angina who are considered for coronary revascularization.
- •Multi-vessel diseases: more than 2 significant coronary de novo lesions (> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate PCI for the complete revascularization of all coronary arteries.
排除标准
- •ST-elevation MI
- •Cardiogenic shock or hemodynamically unstable status
- •Lesions requiring the immediate complete revascularization of all coronary stenotic lesions
- •Contraindication to anti-platelet agents
- •Treated with any DES within 6 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
- •Complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion)
研究组 & 干预措施
Cypher group
干预措施: Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL) (Device)
Xience group
干预措施: Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA) (Device)
Pravastatin group
干预措施: Pravastatin 20mg (Drug)
Atorvastatin group
干预措施: Atorvastatin 40mg (Drug)
结局指标
主要结局
neointimal coverage according to the implanted DES; Xience vs. Cypher
时间窗: up to 12month after stent implantation
Neointimal coverage means percentage of uncovered struts on OCT. The percentages of uncovered struts were compared between EES and SES.
次要结局
未报告次要终点