NCT06841510进行中（未招募）不适用
A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,118
- 试验地点
- 1
- 主要终点
- Device-oriented composite endpoint
研究概览
简要总结
Efficacy and Safety of GENOSS SES in patients with coronary artery disease
详细描述
GENOSS SES
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
- •Patients of 19 and over
- •Patients with coronary artery disease treated with GENOSS SES
- •Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants
排除标准
- •Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
- •Patients who are pregnant or planning to become pregnant
- •Patients with a planned surgery to discontinue antiplatelet agents within 12 months
- •Patients with a life expectancy of less than 1 year
- •Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
- •Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
- •Patients participating in randomized controlled trials using other medical devices
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)
研究者
研究点 (1)
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