A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS DES in Patients with Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,022
- 试验地点
- 1
- 主要终点
- Device-oriented composite endpoint
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.
详细描述
The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of the Genoss DES in all-comer patients undergoing percutaneous coronary intervention.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss DES implantation in all-comer patients undergoing percutaneous coronary intervention from 12 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Device-oriented composite endpoint
时间窗: at 12 months after the procedure
DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).
次要结局
- Patient-oriented composite endpoint(at 12 months after the procedure)
- All-cause deaths(at 12 months after the procedure)
- Cardiac death(at 12 months after the procedure)
- Non-cardiac death(at 12 months after the procedure)
- Any myocardial infarction(at 12 months after the procedure)
- target vessel-related myocardial infarction (TV-MI)(at 12 months after the procedure)
- Any revascularization(at 12 months after the procedure)
- Clinically indicated target lesion revascularization (TLR)(at 12 months after the procedure)
- Stent thrombosis(at 12 months after the procedure)
- Lesion success(during the procedure)
- Procedure success(immediately after the procedure)