NCT01242696已完成不适用
PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the TAXUS® Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,014
- 试验地点
- 37
- 主要终点
- Target Vessel failure
研究概览
简要总结
The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
详细描述
A prospective, open label, multi-center observational study with an all-comers enrollment approach of approximately 1000 subjects at up to 50 sites in Europe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to Instructions For Use
排除标准
- •Contraindications according to Instructions for Use
结局指标
主要结局
Target Vessel failure
时间窗: 1 year
Overall and TAXUS Element stent related Target Vessel Failure (TVF) rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation
次要结局
- Stent Thrombosis(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- MI(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- All Death(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- Cardiac Death or MI(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- Non-Cardiac Death(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- All Death or MI(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- Cardiac Death(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- MACE(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
- TVR(30 days, 6 months, 12 months and then annually through 3 years post index stent implantation)
研究者
研究点 (37)
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