NCT01515228已完成4 期
Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus
CHEOL WHAN LEE, MD, PhD.9 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2012年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 291
- 试验地点
- 9
- 主要终点
- In-segment late luminal loss
研究概览
简要总结
The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.
详细描述
Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 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) Cilotax stent vs. b) Xience Prime stent. 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
- None
入排标准
- 年龄范围
- 21 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients with active treatment (oral agent or insulin)
- •Patients with angina and documented ischemia or patients with documented silent ischemia
- •Patients who are eligible for intracoronary stenting
- •Age > 20 years, < 75 years
- •Angiographic:
- •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)
- •ST-elevation acute myocardial infraction requiring primary stenting
- •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 ≥ 3times normal
- •Renal dysfunction, creatinine ≥ 2.0mg/dL
- •Contraindication to aspirin, clopidogrel or cilostazol
- •Contraindication to Paclitaxel or everolimus
- •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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)
结局指标
主要结局
In-segment late luminal loss
时间窗: at 9 month angiographic follow-up
次要结局
- All Death(9 months)
- Stent thrombosis (by ARC definition)(9 months)
- Cardiac death(9 months)
- Target vessel revascularization (ischemia-driven)(9 months)
- Target lesion revascularization (ischemia-driven)(9 months)
- Myocardial infarction(9 months)
- Procedural success(At discharge from the index hospitalization, an expected average of 3 days.)
- Binary restenosis in both in-stent and in-segment(at 9 month angiographic follow-up)
- Angiographic pattern of restenosis(at 9 month angiographic follow-up)
研究者
CHEOL WHAN LEE, MD, PhD.
MD
CardioVascular Research Foundation, Korea
研究点 (9)
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