Chinese Post-marketing Clinical Study Project Protocol for Evaluate the Safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Target lesion failure (TLF) at 1 years ± 60 days after surgery
研究概览
简要总结
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.
The goal of this study is to assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China.
详细描述
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods. A total of 2,000 subjects will be enrolled from up to 15 research sites in China. Suitable subjects will be selected according to the inclusion and exclusion criteria, and those who meet the inclusion and exclusion criteria will accept follow-up after signing the informed consent form from the site ethics committee until 5 years after surgery. It is aimed to further assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China by observing the data collected in this trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •The subject should be 18 years or older when undergoing the procedure.
- •The subject has signed the Informed Consent.
- •The subject signed Informed Consent dated back within 12 months and was implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
排除标准
- •The subject has or had a life expectancy less then 12 month after treatment with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
- •The subject has any known allergies to the following substances: aspirin, heparin/divalerythromycin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), bivalirudin, rapamycin, L-605 cobalt-chromium (Co-Cr) alloy or its main elements (cobalt, chromium, tungsten and nickel), acrylic acid, fluoropolymer, silicon carbide, PLLA allergy or contraindications.
- •The investigator judges that the subject has poor compliance and cannot complete the study as required, or other circumstances that are not suitable for participation in this study .
结局指标
主要结局
Target lesion failure (TLF) at 1 years ± 60 days after surgery
时间窗: 1 years ± 60 days after surgery
Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).
次要结局
- Serious adverse device effects (SADEs)(1, 2, 3, 4 and 5 years ± 60 days after surgery)
- Major adverse cardiac event (MACE) at 1, 2, 3, 4 and 5 years ± 60 days after surgery(1, 2, 3, 4 and 5 years ± 60 days after surgery)
- Target lesion failure (TLF) at 2, 3, 4 and 5 years ± 60 days after surgery(2, 3, 4 and 5 years ± 60 days after surgery)