Randomized Clinical Comparison of Biomatrix Flex® and Resolute Integrity® Coronary Stents in Non-selected Patients With Ischemic Heart Disease The SORT OUT VI Study*
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,800
- 试验地点
- 6
- 主要终点
- Device-related combined endpoint
研究概览
简要总结
To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.
详细描述
SORT OUT VI is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the Biolimus-eluting Biomatrix Flex and the Zotarolimus-eluting Medtronic Resolute Integrity in treatment of atherosclerotic coronary artery lesions.
Primary Endpoint:
Target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization).
Secondary Endpoints:
Individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the Academic Research Consortium definition (see protocol for further specification of secondary endpoints).
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
- None
入排标准
- 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, prasugrel, sirolimus, or biolimus
- •participation in another randomized trial
- •inability to provide written informed consent
结局指标
主要结局
Device-related combined endpoint
时间窗: 1,2,3 and 5 years
Device-related combined endpoint hierarchically: cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months.
次要结局
- Amount of contrast(12 months)
- Procedure time(12 months)
- Device success rate(12 months)
- Procedure success rate(12 months)
- Fluoroscopy time(12 months)
- Combined endpoint of cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than target lesion, target lesion revascularisation(30 days)
- Target lesion revascularisation(1,2,3 and 5 years)
- Death and myocardial infarction(1 and 12 months)
- Stent thrombosis(1,2,3 and 5 years)
- Device-related combined endpoint hierarchically cardiac death, non-index procedure related AMI, not clearly related to another lesion than target lesion(2,3 and 5 years)
- Patient-related combined endpoint hierarchically: all-cause death, non-index procedure related acute myocardial infarction, all new revascularizations(1,2,3 and 5 years)
- All-cause death(10 years)
研究者
Evald Hoej Christiansen
MD, DMSc
Aarhus University Hospital Skejby