NCT04679740招募中不适用
RMS (Resorbable Magnesium Scaffolds) Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Biotronik AG
- 入组人数
- 1,106
- 试验地点
- 13
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •According to the IFU
排除标准
- •According to the IFU
结局指标
主要结局
Target Lesion Failure (TLF)
时间窗: 12 months
The primary endpoint will be Target Lesion Failure (TLF) at 12 months. TLF is a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Lesion Revascularization (TLR).
次要结局
未报告次要终点
研究者
研究点 (13)
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