NCT01373658Unknown2 期
Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent
Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- late lumen loss
研究概览
简要总结
Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •age 18-80 years old
- •both gender
- •native coronary lesion
- •narrowing > 70%
- •vessel size 2.5-4.0 in diameter
排除标准
- •without informed consent,
- •ST elevation myocardial infarction within 7 days,
- •patient with ≤ 70% coronary narrowing at target lesion,
- •left main lesion,
- •multivessel narrowing need more than 3 stent implantations,
- •by-pass graft,
- •abnormal liver function before randomization,
- •active hepatitis or muscular disease,
- •impaired renal function with serum creatinine level > 3mg/dl,
- •impaired left ventricular function with LVEF < 30%,
- •participate in other studies.
结局指标
主要结局
late lumen loss
时间窗: 12 months
Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 12-month angiographic follow-up.
次要结局
- major adverse cardiac events(12 months)
研究者
研究点 (1)
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