A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study toevaluate the safety and performance of Vector® PTCA Balloon Catheter in real-world settings.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Major Adverse Cardiac Events
研究概览
简要总结
A retrospective, single-arm, multi-center, observational, post-market clinical follow-up study to evaluate the safety and performance of Vector PTCA Balloon Catheter The Vector PTCA Balloon Catheter is also indicated for post-delivery expansion of balloon expandable stents .All consecutive patients who had been treated with Vector PTCA Balloon Catheter for balloon dilatation of stenotic portion of coronary artery or by pass graft stenosis for improving myocardial perfusion and/or post-delivery expansion of balloon expandable stents. The study Population is about 125 patients and The objective of this study is to evaluate the safety and performance of Vector PTCA Balloon Catheter in real-world settings.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who had been treated with Vector PTCA balloon Catheter.
排除标准
- 未提供
结局指标
主要结局
Major Adverse Cardiac Events
时间窗: 12 Months
次要结局
- Procedural success(Device Success)