NCT00856765已完成2 期
Randomized Comparison of Drug Eluting Balloon/Bare Metal Stent Versus Drug Eluting Stent Versus Bare Metal Stent for the Treatment of Patients With Acute ST-elevation Myocardial Infarction
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)
研究概览
简要总结
The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combination without impairing the process of normal vascular healing and endothelial function.
The goals of this study are:
- To compare 6-month angiographic outcome after primary angioplasty using drug eluting balloon/bare metal stent combination versus drug eluting stent versus bare metal stent.
- To compare stent apposition and stent endothelialization after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
- To compare coronary endothelial function after primary angioplasty using drug eluting balloon/bare metal stent versus drug eluting stent versus bare metal stent.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STEMI within 12 hours of onset of complaints
- •Candidate for primary PCI with stent-implantation
- •Successful thrombus aspiration defined by no angiographic signs of thrombus a the site of plaque rupture and TIMI flow more or equal 1
排除标准
- •Unable to give written informed consent
- •Diabetes and Type C- coronary lesion
- •Previous PCI or CABG of infarct related vessel
- •Left main stenosis more than 50%.
- •Triple vessel disease with stenosis more than 50% in 3 epicardial coronary arteries
- •Target vessel reference diameter less than 2.5 and more than 4.0 mm
- •Target lesion length more than 25 mm
- •Intolerance for aspirin or clopidogrel
- •Life expectancy less than 12 months
- •Women with child bearing potential
结局指标
主要结局
Angiographic in-segment late lumen loss (expressed in millimeters) as determined by quantitative coronary analysis (QCA)
时间窗: 6 months
次要结局
- stent malapposition and re-endothelialization assessed by Optical Coherence Tomography (OCY)(6 months)
- coronary endothelial dysfunction after acetylcholine infusion(6 months)
- Clinical outcomes (death, myocardial infarction, repeated revascularization procedures)(5 years)
- Binary restenosis using QCA(6 months)
研究者
研究点 (3)
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