Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent in Routine Clinical Practice: A Prospective, Single-arm, Multicenter, Observational Study (The GENCOMX Registry)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Target Lesion Failure (TLF)
研究概览
简要总结
In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.
详细描述
This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent.
As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions during the study registration period.
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
Target Lesion Failure (TLF)
时间窗: at 12 months after the procedure
The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)
次要结局
- All deaths(at 12 months after the procedure)
- Cardiac death(at 12 months after the procedure)
- TV-MI (target vessel-myocardial infarction)(at 12 months after the procedure)
- any MI (myocardial infarction)(at 12 months after the procedure)
- ID-TVR (ischemia-driven target vessel revascularization)(at 12 months after the procedure)
- ID-TLR (ischemia-driven target lesion revascularization)(at 12 months after the procedure)
- Stent thrombosis by ARC definition(at 12 months after the procedure)
- Procedure success(during the hospitalization period (up to 3 days))