A Prospective, Randomized, Multicenter Comparison of the Drug-Eluting Stent Systems YUKON Choice and TAXUS Liberté in Patients With Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- "In-stent late lumen loss" at follow-up-angiography (9 months)
研究概览
简要总结
Revascularisation procedures such as percutaneous coronary intervention are associated with overall worse outcomes in patients with diabetes mellitus. Implantation of coronary stents is associated with higher restenosis rates compared to non-diabetic individuals.
There is only limited data available on the efficacy and safety of the novel Yukon Choice drug-eluting stent system specifically in patients with diabetes mellitus. The trial will determine the efficacy and safety of the novel Yukon Choice stent system compared to the well established Taxus Liberté stent system. The primary endpoint will be "in-stent late lumen loss" at 9 months as determined by invasive angiography.
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
- •age > 18 years
- •diabetes mellitus
- •symptoms (stable or unstable angina pectoris) or objective evidence of myocardial ischemia
- •one or more de novo lesions in 1, 2 or 3 native coronary arteries
- •clinically significant diameter of stenosis (50-99 % according to visual assessment of operator)
- •lesion must be covered by stent length of no more than 24 mm and stent diameter of no more than 3,5 mm
- •vessel diameter of no more than 4 mm in vessel area adjacent to stenosis
- •informed consent
排除标准
- •unprotected left main disease
- •complete occlusion of target vessel
- •in-stent-restenosis
- •stenoses of bypass grafts
- •indication for bypass surgery
- •bifurcation lesions (side branch > 2,0 mm)
- •thrombus in target lesion as visualized by angiography
- •allergy or contraindication to concomitant medication (clopidogrel, aspirin, heparin, contrast media)
- •acute myocardial infarction within preceding 48h
- •participation in another trial
- •pregnancy
- •severe disorder of coagulation or platelet function
结局指标
主要结局
"In-stent late lumen loss" at follow-up-angiography (9 months)
时间窗: 9 months
次要结局
- Binary restenosis(9 months)
- Target vessel revascularisation rate(9 months)
- Combined MACE (cardiac death, myocardial infarction, emergency bypass, stent thrombosis, target lesion revascularization)(9 months)
- Target lesion revascularisation rate(9 months)
- Late loss (in-segment)(9 months)
- MLD und diameter of stenosis (%)(9 months)
- Death(9 months)
- Success rate index procedure (residual diameter stenosis < 30%)(0 months)