NCT01794065Unknown不适用
The Promus Element Rewards Study
Medstar Health Research Institute1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2012年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Stent length
研究概览
简要总结
This study is being done to study stent deformation on persons with de novo coronary lesions to determine how much deformation takes place and how often. The information gathered from the group that receives the Promus element stent will be compared to other groups that receive other contemporary drug eluting stents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients, male or female, 18 years or older;
- •Patients with de-novo coronary lesions and slated to receive a Promus Element stent;
- •Patients who are slated to undergo IVUS after stent deployment during implantation procedure
排除标准
- •Patients receiving more than one drug-eluting stent within the same lesion during implantation procedure;
- •Patients with in-stent restenosis;
- •Patients who had IVUS imaging attained with manual pullback.
结局指标
主要结局
Stent length
时间窗: 1 day
The primary endpoint of this study will be to assess the overall change in stent length post deployment by intravascualar ultrasound (IVUS) between the 5 stent groups.
次要结局
- IVUS stent length(1 day)
研究者
研究点 (1)
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