A Multicenter, Randomized Trial to Compare Xience and Vision Coronary Stents in the Same Multivessel Patient With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 215
- 试验地点
- 4
- 主要终点
- Ischemia-driven target vessel revascularization
研究概览
简要总结
Percutaneous coronary intervention (PCI) with bare metal stent (BMS) in patients with renal insufficiency has shown unsatisfactory results. Indeed, drug-eluting stents (DES) might reduce the incidence of restenosis and therefore of target lesion revascularization procedures in these patients.
We therefore designed a prospective, randomized, multicenter, not-sponsored study to directly compare the efficacy in the prevention of clinical restenosis of everolimus-eluting stent (Xience V) and bare-metal stent (Vision) (both 2nd-generation DES and BMS, respectively), both implanted in the same patient with multivessel disease and renal insufficiency in order to obviate for the multiple and unpredictable characteristics of this high-risk population.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic renal insufficiency (creatinine clearance <60 ml/min, in dialysis patients included) with at least two significant (>70%) coronary lesions in two major coronary vessels.
排除标准
- •Age >85 years
- •left main coronary artery disease
- •saphenous vein graft disease
- •ST-elevation MI (<3 days)
- •coronary vessel diameter <2.5 or > 4 mm
- •contraindication to long-term double antiplatelet therapy
- •CABG indication by consensus (cardiovascular team)
- •severe valvular heart disease
- •informed consent not obtained
结局指标
主要结局
Ischemia-driven target vessel revascularization
时间窗: 9 months
次要结局
- Incidence of death and myocardial infarction(in-hospital, 30 days, 9 and 12 months)
研究者
Fabrizio Tomai
MD, FACC, FESC
European Hospital