Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 入组人数
- 3,150
- 试验地点
- 2
- 主要终点
- Target Lesion Failure
研究概览
简要总结
The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events
详细描述
SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions.
Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent (Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web based Trial Partner randomization system will be used.
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
- •Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.
排除标准
- •Life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.
结局指标
主要结局
Target Lesion Failure
时间窗: 12 months
Primary endpoint assessed after 12 months
次要结局
- Target lesion revascularization(1 year, 2 years, 3 years, 4 years, 5 years)
- Target lesion failure(2 year, 3 year, 4 year, 5 year)
- Cardiac death(1 year, 2 years, 3 years, 4 years, 5 years)
- All cause mortality(1 year, 2 years, 3 years, 4 years, 5 years)
- Stent thrombosis(1 year, 2 years, 3 years, 4 years, 5 years)
- Myocardial infarction(1 year, 2 years, 3 years, 4 years, 5 years)
- Target vessel revascularization(1 year, 2 years, 3 years, 4 years, 5 years)
研究者
Lisette Okkels Jensen
MD DMSci PhD
Odense University Hospital