Real World Drug-Eluting Stent Prospective, Open, Multi-site, Registry in Korea: BioMimeTM Stent, Ultimaster® Stent vs. Xience® Stent By SMart Angioplastry Research Team (SMARTDESK-MX)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- The incidence of 1-year target lesion failure
研究概览
简要总结
Comparison of safety and long-term effects of BioMimeTM stent and Ultimaster® stent with Xience® stent
详细描述
A prospective, open, multicenter, and observational study will register and compare Xience® groups treated in institutions such as the BioMime ™, Ultimaster® group prospectively registered from June 2016.
The Xience® group has already been registered in the previous study (SMARTDESK-BX), so BioMimeTM and Ultimaster® only need to be registered. Follow-up will be conducted until December 2019, and e-CRF will be completed by April 2020.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •19 years old or older
- •Clinical evidence of coronary artery disease including asymptomatic ischemia, stable angina pectoris, acute coronary syndrome (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction).
- •Vessel diameter 2.25 ~ 3.5mm, stenosis more than 50% (However, the number of blood vessels, the number of lesions, and the lesion length are not limited)
- •Voluntary written consent to participate in the trial
排除标准
- •Within 24 hours before percutaneous coronary intervention, hemodynamic instability or cardiogenic shock
- •Life expectancy within 2 years
结局指标
主要结局
The incidence of 1-year target lesion failure
时间窗: 1-year
The incidence of 1-year target lesion failure (combination of cardiac death, target vessel myocardial infarction, and target vessel revascularization).
次要结局
- Incidence of 30-day and 2-year target lesion failure(30-day and 2-year)
- Incidence of 30-day, 1-year, and 2-year deaths(30-day, 1-year, and 2-year)
- Incidence of 30-day, 1-year, and 2-year cardiac events(30-day, 1-year, and 2-year)
- Incidence of 30-day, 1-year, and 2-year myocardial infarction(30-day, 1-year, and 2-year)
- Incidence of 30-day, 1-year, and 2-year target vessel myocardial infarction(30-day, 1-year, and 2-year)
- Incidence of 30-day, 1-year, and 2-year revascularization(30-day, 1-year, and 2-year)
- Incidence of 30-day, 1-year, and 2-year target revascularization(30-day, 1-year, and 2-year)
- Incidence of 30-day, 1-year, and 2-year stroke(30-day, 1-year, and 2-year)
- Incidence of acute stent thrombosis at 24 hours, subacute stent thrombosis at 30 days, and stent thrombosis at 1 and 2 years(24 hours, 30 days, 1 and 2 years)
研究者
Hyeon-Cheol Gwon
Professor
Samsung Medical Center