NCT00755443已完成4 期
A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography
研究概览
简要总结
The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de novo coronary artery stenosis.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic either non-insulin or insulin-dependent (according to World Health Organization Report) on pharmacologic treatment (insulin or hypoglycaemic agents) for at least 1 month, and presented de novo coronary stenoses in 1,2 or 3 native vessels with symptoms or objective evidence of ischemia. Stenoses had to be amenable for stent implantation, with vessel size smaller than 4.0 mm (as assessed visually on angiography)
排除标准
- •Impaired glucose tolerance without pharmacologic treatment, gestational diabetes or transient hyperglycaemia
- •Stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main or involving important side branches (> 2 mm) that should be treated during the procedure
- •Left ventricle ejection fraction < 25%
- •Prior treatment with intracoronary brachytherapy or other drug eluting stent at target site
- •Restenotic lesions; known allergies to aspirin, ticlopidine and clopidogrel acute coronary syndromes with persistent ST elevation < 72 hours and/or CPK twice the upper normal limit
- •Non-ST elevation acute coronary syndromes with CPK twice the upper normal limit
- •Severe hepatic or renal disease (creatinin clearance < 30 ml/min or hepatic enzymes twice the upper normal limit); and life expectancy < 1 year
结局指标
主要结局
The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography
时间窗: 270-day follow-up
次要结局
- Other angiographic parameters of restenosis such as binary restenosis, and minimal luminal diameter; major adverse cardiac events including cardiac death, myocardial infarction, target lesion (in-segment zone) revascularization stent thrombosis(1, 9, 12 and 24-month follow-up)
研究者
研究点 (2)
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