Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study
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
The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.
详细描述
This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.
This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.
As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants 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
- Major adverse cardiac events (MACE)(at 12 months after the procedure)
- Cardiac death(at 12 months after the procedure)
- Non-cardiac death(at 12 months after the procedure)
- TV-MI (target vessel-myocardial infarction)(at 12 months after the procedure)
- Non-target vessel myocardial infarction(at 12 months after the procedure)
- ID-TVR (ischemia-driven target vessel revascularization)(at 12 months after the procedure)
- Non-ischemia driven target vessel revascularization(at 12 months after the procedure)
- Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year(within 24 hours, 30 days, 1 year)
- Device success(during the procedure)
- Procedure success(during the hospitalization period (up to 3 days))