NCT01489449已完成4 期
Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
University Hospital, Saarland2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2012年12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
- 210
- 试验地点
- 2
- 主要终点
- MACE
研究概览
简要总结
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.
详细描述
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint will be MACE (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.
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 (Outcomes Assessor)
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
- •NSTEMI with
- •Ischemic symptoms (angina pectoris) > 30 minutes
- •Last symptoms within 72 hours before randomization
- •Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
- •age > 18 years
- •Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed)
排除标准
- •Cardiogenic shock
- •ST-elevation myocardial infarction
- •No identifiable culprit lesion, Indication for acute bypass surgery
- •Comorbidity with limited life expectancy < 9-12 months
- •Contraindication for treatment with heparin, ASA and thienopyridines
结局指标
主要结局
MACE
时间窗: 9 months
MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization
次要结局
- Reinfarction(9 months, 3 years, 5 years)
- any revascularization(9 months, 3 years, 5 years)
- Stent thrombosis (ARC(9 months, 3 years, 5 years)
- Mortality (cardiac and non-cardiac)(9 months, 3 years, 5 years)
- target lesion revascularization(9 months, 3 years, 5 years)
- target vessel revascularization(9 months, 3 years, 5 years)
研究者
研究点 (2)
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