Comparison of the Everolimus Eluting (XIENCE-V®, XIENCE-Prime® or PROMUS® Stent) With the Biolimus A9 Eluting NOBORI® Stent in All-comers: a Randomized Open Label Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 2,700
- 试验地点
- 11
- 主要终点
- Major adverse coronary events
研究概览
简要总结
This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.
详细描述
The main objective of the study is a head to head comparison of the everolimus eluting XIENCE-V ®, XIENCE-Prime® or PROMUS ® stent with the biolimus A9 eluting NOBORI® stent in order to observe whether there is a difference in clinical outcome between both stents in a real world / all-comer situation.
Clinical outcome of both stents will be assessed by the composite end point of: cardiac death, non fatal myocardial infarction and target vessel revascularization.
Endpoints
The primary end point of the study is the composite of safety (cardiac death, non fatal myocardial infarction) and efficacy (target vessel revascularization) at 12 months.
The secondary end points of the study are:
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
- •The patient is at least 18 years old and has a life expectancy of 5 years.
- •Patient undergoes a PCI procedure for indications according to the Dutch and European guidelines
- •Patient is willing to comply with the extended follow-up period of 2 to 5 years(for secondary endpoint only)
- •Reference lumen diameter of the treated vessels between 2.0 - 4.0 mm.
- •Informed consent
排除标准
- •Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
- •Expected major surgery within 30 days (these patients will receive bare metal stents)
- •Cardiogenic shock (Kilip class 4)
- •Previous PCI procedures with implantation of drug eluting stents within 1 year.
- •Expected loss for follow up
- •Enrollment in an investigative stent study with different stents
- •Inability to implant Nobori or Xience-V / Promus stent(s)
结局指标
主要结局
Major adverse coronary events
时间窗: 12 months
composite of cardiac death, non fatal myocardial infarction and target vessel revascularization
次要结局
- Major adverse coronary events(12 months)
- Safety of stenting with drug eluting stents(5 years)
- Target lesion revascularization(5 years)
- Late major adverse coronary events(5 years)
- Stent Thrombosis(5 years)
- Major adverse coronary events in subgroups(5 years)
- Procedural performance(1 year)