Evaluation of Effectiveness and Safety of Synergy™ XD Stent and Synergy Megatron™ Stent in Routine Clinical Practice; A Multicenter, Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 22
- 主要终点
- The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization
研究概览
简要总结
The objective of this study is to evaluate the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stent in the "real world" daily practice as compared with the other drug-eluting stents.
详细描述
This study is a non-randomized, prospective, open-label registry to compare the effectiveness and safety of Synergy XD stent and Synergy Megatron™ Stents versus other drug-eluting stents (DES) in patients with coronary artery disease.
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
- •Patients ≥ 19 years old
- •Patients receiving Synergy XD stent(s) or Synergy Megatron™ stent(s).
- •The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
排除标准
- •Patients with a mixture of other drug-eluting stents (DESs)
- •Terminal illness with life-expectancy ≤1 year.
- •Patients with cardiogenic shock
结局指标
主要结局
The composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization
时间窗: 1 year
A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed.
次要结局
- The event rate of myocardial infarction(5-year)
- The event rate of target-vessel revascularization(5-year)
- The composite event rate of death or myocardial infarction(5-year)
- The composite event rate of cardiac death or myocardial infarction(5-year)
- The event rate of all death(5-year)
- The event rate of cardiac death(5-year)
- The event rate of stent thrombosis(5-year)
- The event rate of procedural success(3 days)
- The event rate of target-lesion revascularization(5-year)
- The event rate of stroke(5-year)
研究者
Jung-min Ahn
Assistant professor of Medicine, Division of Cardiology, Department of Internal Medicine
Asan Medical Center