NCT00388934已完成4 期
Randomized Clinical Comparison of Cypher Select and Taxus Express Stent Implantation in Unselected Patients With Coronary Artery Disease.
Aarhus University Hospital Skejby0 个研究点目标入组 2,095 人开始时间: 2004年8月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,095
- 主要终点
- MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)
研究概览
简要总结
Randomized nine months clinical comparison of implantation of Taxol eluting (Taxus Express) and Sirolimus eluting (Cypher Select) stents in non-selected patients with coronary artery disease.
详细描述
Design:
- Randomized open multicentre trial.
Patients:
- 1800 patients with coronary artery disease scheduled for percutaneous coronary intervention with stent implantation.
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Planned implantation of drug eluting stent
- •Written informed consent
排除标准
- •Planned intervention with other stents than study stents
结局指标
主要结局
MACE (cardiac death, myocardial infarction, target vessel revascularisation, target lesion revascularisation, TVF)
时间窗: during 9 months
次要结局
- Total death(after 9 months, 2 and 3 years)
- Cardiac death(after 9 months, 2 and 3 years)
- Myocardial infarction(after 9 months, 2 and 3 years)
- Target vessel revascularisation, target lesion revascularisation, TVF(after 9 months, 2 and 3 years)
- Stent thrombosis(after 9 months, 2 and 3 years)
研究者
相似试验
已完成
4 期
The Intra-Drug Eluting Stent (DES) Restenosis StudyCoronary Artery DiseaseNCT00323895Cordis Corporation320
已完成
1 期
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced CancerNeoplasmNCT00100139INSYS Therapeutics Inc48
已完成
4 期
The REALITY Study - Head-to-Head Comparison Between Cypher and TaxusCoronary Artery DiseaseNCT00235092Cordis US Corp.1,335
已完成
1 期
Phase II Study of Taxotere in Combination With Exisulind in Non-Small Cell Lung Cancer (NSCLC) PatientsNSCLCNCT00072618Astellas Pharma Inc52
招募中
3 期
A Study to Compare the Efficacy and Safety of TachoSil and Surgicel Original as an Adjunct to Control Mild to Moderate Soft Tissue Bleeding During SurgeryHemorrhageNCT06664775Corza Medical GmbH116