Randomized Clinical Comparison of the Combined Sirolimus Eluting and Endothelial Progenitor Cell Combo™ Stent and the Biolimus Eluting Absorbable Polymer Coated BioMatrix Alpha™ Stent in Patients Treated With Percutaneous Coronary Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,141
- 试验地点
- 4
- 主要终点
- Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
研究概览
简要总结
SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.
详细描述
Randomized clinical comparison of the Sirolimus eluting and endothelial progenitor cell Combo™ stent and the Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent in patients 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
- 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 Aarhus, Odense 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 speak Danish
- •The patient is already included in the SORT OUT XI study
- •Life expectancy <1 year
- •Allergic to study related treatment
结局指标
主要结局
Device-related Target Lesion Failure (TLF) The composite of cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven target-lesion revascularization
时间窗: Within 12 months
The primary endpoint will be analyzed using the Kaplan-Meier method. Hazard ratios between groups will be calculated using a Cox proportional hazard model and the primary endpoint in the two per protocol treated groups will be compared with an upper one-sided 95% confidence interval. Patients treated with the ComboTM stent will be used as the reference group.
Target Lesion Revascularisation (TLR)
时间窗: Within 12 months
Repeat/new revascularization (PCI or CABG) within the stent or within a 5-mm border proximal or distal to the stent. (Angina, CCS \> 1 related to the index lesion/vessel and diameter stenosis ≥ 50%. Diameter stenosis will be assessed by eyeballing, FFR \<0.80, or iFR\< 0.90). TLR will be clinically driven.
次要结局
- Target Vessel Revascularization due to clincal symptoms(Through 5 years)
- Individual components of the primary end point comprise the secondary end points(Clinical follow-up will be continued through 5 years)
- Number of participants with Cardiac Death(Through 5 years)
- Target Lesion Revascularization due to clincal symptoms(Through 5 years)
- Number of patients with all cause mortality(Through 5 years)
- Number of participants with Myocardial Infarction(Through 5 years)
- Number of patients with stent thrombosis(Through 5 years)
- Number of patients with Patient-related composite end point(Through 5 years)
研究者
Phillip Freeman
Principal Investigator, MD
Aalborg University Hospital