Randomized Clinical Comparative Study of the Nobori and the Cypher Stents in Unselected Subjects With Ischemic Heart Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,504
- 试验地点
- 6
- 主要终点
- Primary outcome
研究概览
简要总结
To perform a randomized comparison between the Cypher Select+ stent and the Nobori stent in the treatment of unselected patients with ischaemic heart disease.
详细描述
All patients to be treated with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg and Varde can be included in the study. All patients enrolled in the study will be hospitalized at one of the heart centers mentioned. Patients will not be recruited via advertisements.
The study is designed as a non-inferiority study, where the objective is to prove that Nobori is Δ0 poorer as a maximum than Cypher select+. The nine-month event rate (cardiac death, MI and/or TVR) in the Cypher stent group of SORT OUT 3 was 3.0%
The calculation of power below has been made under the following assumptions:
P (Cypher) = 0.03
There is no good estimate for the event rate related to the Nobori stent. α = 0.05 - one-sided
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients eligible for treatment with one or several drug-eluting coronary stents at one of the four heart centers in Odense, Skejby, Aalborg or Varde can be included in the study.
- •The patients will be treated in accordance with the criteria applicable at the individual sites. The indication for using DES varies slightly between the four sites, as the indication for implantation of DES is based on clinical and angiographic criteria with the financial constraints applying at the individual site. Basically, DES will be chosen instead of BMS in patients with an estimated increased risk of restenosis, in patients with the following stenosis types: Long lesions, lesions in small vessels, bifurcations, ostial lesions, in-stent restenoses and stenosis in the proximal segment of the anterior descending branch. Furthermore, DES will also be chosen for diabetics and in the left main.
排除标准
- •The patient does not wish to participate
- •The patient is participating in other randomized stent studies
- •Life expectancy < 1 year
- •Allergic to Aspirin, clopidogrel, prasugrel or ticlopidin
- •Allergic to sirolimus or biolimus
研究组 & 干预措施
Nobori
Percutaneous coronary intervention with implantation of coronary stent (Nobori)
干预措施: Percutaneous coronary intervention (PCI) (Procedure)
Cypher
Percutaneous coronary intervention with implantation of coronary stent (Cypher)
干预措施: Percutaneous coronary intervention (PCI) (Procedure)
结局指标
主要结局
Primary outcome
时间窗: Within 9 months
Major Adverse Cardiac Events, such as cardiac death, myocardial infarction, stent thrombosis or target lesion revascularisation: repeated revascularisation of an index lesion at PCI or bypass surgery
次要结局
- Major Adverse Coronary Events(30 days)
- Acute Myocardial Infarction(30 days and 9 months)
- Target lesion revascularisation defined as repeated revascularisation of an index lesion at PCI or bypass surgery.(9 and 12 months and 3 years)
- Death(30 days and 9 months)
- Secondary outcome
- Stent thrombosis(12, 24 and 36 months)
研究者
Evald Hoej Christiansen
MD. DMSc
Aarhus University Hospital Skejby