A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of 1 Year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-Risk Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Device-oriented composite endpoint
研究概览
简要总结
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
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 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented 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. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization 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
- •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 with cardiogenic shock at the time of hospitalization
- •Patients who are pregnant or planning to become pregnant
- •Patients with a life expectancy of less than 1 year
- •Patients participating in randomized controlled trials using other medical devices
- •Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)
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-realted myocardial infarction (TV-MI)(at 12 months after the procedure)
- Any revascularization(at 12 months after the procedure)
- Revascularization of clinically appropriate target lesions(at 12 months after the procedure)
- Stent thrombosis by ARC definition(at 12 months after the procedure)
- Lesion success(during the procedure)
- Procedure success(immediately after the procedure)