Randomized Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention in an All Comer Population (The SORT OUT XII Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,150
- 试验地点
- 3
- 主要终点
- Number of patients with target lesion failure
研究概览
简要总结
The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents
排除标准
- •Age < 18 years
- •Not able to consent to study participating (eg. intubated patients)
- •Unstable circuit or in cardiogenic shock and therefore not able to understand the information and purpose of the study
- •Do not speak Danish
- •Already included in the SORT OUT XII study
- •Life expectancy <1 year
- •Allergic to study related treatment
研究组 & 干预措施
Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent
Percutaneous coronary interventin with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent
干预措施: Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s) (Device)
Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent)
Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent)
干预措施: PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s)) (Device)
结局指标
主要结局
Number of patients with target lesion failure
时间窗: 1 year
Target lesion failure (TLF) is a composite of cardiac death, myocardial infarction (not clearly attributable to a non-intervention lesion) or target lesion revascularization with percutaneous coronary intervention or coronary artery bypass operation
次要结局
- Number of patients with all-cause death(1 year, 3 years and 5 years)
- Number of patients with cardiac death(1 year, 3 years and 5 years)
- Number of patients with myocardial infarction(1 year, 3 years and 5 years)
- Number of patients with definite stent thrombosis(1 year, 3 years and 5 years)
- Number of patients with probable stent thrombosis(1 year, 3 years and 5 years)
- Number of patients with target lesion revascularization(1 year, 3 years and 5 years)
- Number of patients with target vessel revascularization(1 year, 3 years and 5 years)