Randomized Clinical Comparison of Everolimus-Eluting SYNERGY® and Biolimus-Eluting BioMatrix NeoFlex® Coronary Stents in Non-Selected Patients With Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,800
- 试验地点
- 6
- 主要终点
- Device-related target lesion failure
研究概览
简要总结
The purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.
详细描述
SORT-OUT VIII is a randomised, multicenter, all-comer, two-arm, non-inferiority trial comparing the everolimus-eluting SYNERGY stent versus the Biomatrix NeoFlex stent in treatment of atherosclerotic coronary artery lesions.
Primary Endpoint:
Device-related Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related acute myocardial infarction (AMI) not clearly related to another lesion than the target lesion, or target lesion revascularisation (TLR) (new revascularization of target lesion) (significant stenosis in the stent ± 5 mm distal/proximal) by percutaneous coronary intervention (PCI) or coronary artery bypass operation (CABG) within 12 months.
Secondary Endpoint:
Device-related target lesion failure hierarchically as cardiac death, non-index procedure related acute myocardial infarction, not clearly related to another lesion than the target lesion, or new target lesion revascularization by percutaneous coronary intervention or coronary bypass operation at 2-5 years.
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
- 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 at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.
排除标准
- •Age < 18 years
- •The patient does not wish to participate
- •The patient is not able to consent to randomization (eg intubated patients)
- •The patient do not live in West Denmark
- •The patient do not speak Danish
- •The patient is already included in this study
- •The patient is already participating in other stent studies
- •Life expectancy <1 year
- •Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor
- •Allergic to everolimus or biolimus
- •Only implanted BMS
- •Only performed POBA
结局指标
主要结局
Device-related target lesion failure
时间窗: 12 months
Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation (significant stenosis in the stent =/+ 5 mm distal/proximal) by percutaneous coronary intervention or coronary artery bypass operation
次要结局
- Patient-related combined endpoint(1, 2, 3, 4 and 5 year)
- Individual above mentioned stent- or patient-related endpoints(1, 2, 3, 4 and 5 years)
- Stent thrombosis(Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years)
- Device-related target lesion failure(2, 3, 4 and 5 years)
- MACE(1, 2, 3, 4 and 5 years)
- Device success rate(intraoperative)
研究者
Michael Mæng
MD
Aarhus University Hospital Skejby