Randomized Comparison of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Implantation for De Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 11
- 主要终点
- Angiographic in-segment late loss
研究概览
简要总结
The purpose of this study is to establish the safety and effectiveness of coronary stenting with the Zotarolimus-Eluting stent compared to the Sirolimus-Eluting stent in the treatment of de novo coronary stenosis in patients with diabetic patients.
详细描述
Prospective, two arms, single blind, randomized multi-center trial of 380 patients enrolled at 24 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Endeavor Resolute stent vs. b) Cypher select. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.
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
- Single (Participant)
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
- •Diabetic patients with angina and documented ischemia
- •Patients who are eligible for intracoronary stenting
- •De novo lesion
- •Percent diameter stenosis ≥50%
- •Reference vessel size ≥ 2.5 mm by visual estimation
排除标准
- •History of bleeding diathesis or coagulopathy
- •Pregnant state
- •Known hypersensitivity or contra-indication to contrast agent and heparin
- •Limited life-expectancy (less than 1 year)
- •Acute ST elevation myocardial infarction on admission
- •Characteristics of lesion Left main disease In-stent restenosis Graft vessels
- •Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
- •Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
- •Renal dysfunction, creatinine ≥ 2.0mg/dL
- •Contraindication to aspirin, clopidogrel or cilostazol
- •Left ventricular ejection fraction <30%
- •Patients who are actively participating in another drug or device - investigational study, which have not completed the primary endpoint follow- up period.
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
结局指标
主要结局
Angiographic in-segment late loss
时间窗: 9-month angiographic follow-up
次要结局
- Death (all-cause and cardiac)(at 12 months)
- myocardial infarction(at 12 months)
- stent thrombosis(at 12 months)
- target-lesion revascularization(at 12 months)
- target-vessel revascularization(at 12 months)
研究者
Seung-Jung Park
M.D., Ph.D.,Professor of Medicine Asan Medical Center, University of Ulsan, College of Medicine
CardioVascular Research Foundation, Korea