A multicenter, observational, real-world, safety and performance evaluation of BioMimeâ„¢ Morph Sirolimus-Eluting Coronary Stent System for coronary artery lesions.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Major Adverse Cardiac Events (MACE)
研究概览
简要总结
This is a retrospective, multicenter, observational, real-world, study to evaluate safety and performance of BioMimeâ„¢ MorphSirolimus Eluting Coronary Stent Systemsin the treatment ofapproximately 400 patients with coronary artery lesions at approximately5-10 centers.
The objective of the study is to evaluate safety and performanceof BioMime in the real world settings at specific time point [Time frame: 2years follow up].
All Subjects will be approached to sign ICF approved by respectiveethics committee before starting the study related process. A list of allthe potential patients that have been treated with Sirolimus Eluting CoronaryStent Systems will be selected for the study.
As this is a retrospective study, the patients will be followed up foronly observation and the data will be collected.
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 have been treated with BioMimeâ„¢ Morph.
- •Patients who are contactable, willing to participate will be taken into the study by signing voluntary informed consent form.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Major Adverse Cardiac Events (MACE)
时间窗: 2 years follow up
次要结局
- Target vessel failure (TVF), Stent Thrombosis, Procedure Success, Device Success(2 years follow up)