Multi-centre, Randomised,Prospective Trial of Xience or Vision Stent, Management of Angina in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage
研究概览
简要总结
The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.
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
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina or acute coronary syndrome
- •Coronary narrowing suitable for stenting that is either ≥15mm long and/or ≤3mm diameter.
- •Any lesion with high risk of restenosis eg chronic total occlusion, bifurcation, severe calcification
- •Any left main stem lesion
排除标准
- •Acute ST segment elevation myocardial infarction
- •Cardiogenic shock
- •Platelet count =50 x 109/mm3
- •Patient life expectancy < 1 year
- •Known allergies to clopidogrel, aspirin, heparin, stainless steel, IV contrast or stent drug elutant
- •Recent major GI haemorrhage (within 3 months)
- •Any previous cerebral bleeding episode
- •Participation in another investigational drug or device study
- •Patient unable to give consent
- •Clinical decision precluding the use of drug eluting stent
研究组 & 干预措施
Drug eluting stent
Percutaneous coronary intervention
干预措施: Percutaneous Coronary Intervention using drug eluting stents (Procedure)
Bare Metal Stent
Percutaneous Coronary Intervention
干预措施: Percutaneous Coronary Intervention using bare metal stents (Procedure)
结局指标
主要结局
Death/ Myocardial Infarction/Target Vessel Failure/Major Haemorrhage
时间窗: 1 year
This is a composite outcome measure consisting of multiple measures of the events of Death, Myocardial Infarction,Target Vessel Failure, and/or Major Haemorrhage
次要结局
- Antianginal medication(1 year)
- Angina status(1 year)
- Procedural success(1 Year)
- MACE (major adverse cardiovascular events)(1 year)
- In-hospital complications(1 Year)
- Procedural cost(1 Year)
研究者
Adam de Belder
Consultant Cardiologist
Brighton and Sussex University Hospitals NHS Trust