NCT00955214Unknown4 期
Impact of Paclitaxel-eluting Stent for Small Coronary Artery Disease
Society for Advancement of Coronary Intervention Research45 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2009年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 250
- 试验地点
- 45
- 主要终点
- Target lesion revascularization rate
研究概览
简要总结
The utilization of paclitaxel-eluting coronary stents in small vessel diseases is effective in reducing both repeat revascularization and major adverse cardiac events within two year follow-up. To evaluate the procedural, short and long term clinical outcomes of the Taxus Liberte™ Paclitaxel-Eluting Coronary Stent in small coronary arteries of ≤ 2.5 mm in the reference vessel diameter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 years and are able to undergo CABG
- •Females who are not pregnant
- •Patients who present with angina symptoms or myocardial ischemia
- •Patients available for post-procedural observation and coronary angiography at 24 months
- •Patients who have signed patient informed consent
- •Lesion which is eligible for only one 2.5mm paclitaxel-eluting stent
- •De novo lesion or non-stented restenosed lesion
排除标准
- •Patients contraindicated for antiplatelet therapy or anticoagulant therapy
- •Patients with significant allergic reaction to contrast medium
- •Chronic total occlusion
- •Lesion with TIMI0
- •Lesion which is needed more than two stents
- •Patients with chronic renal failure (SCr>3.0mg/dl) -
结局指标
主要结局
Target lesion revascularization rate
时间窗: within 9months
次要结局
- Technical success(initial)
- Target lesion revascularization rate(24 months)
- Target vessel revascularization rate(24 months)
- The rate of MACE including MI due to stent thrombosis(24 months)
研究者
研究点 (45)
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