Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Patient radiation exposure (mGy)
研究概览
简要总结
Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise.
The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for a elective coronary angiography
- •Eligible for either transfemoral or transradial approach
- •Accept to sign the written consent form (WCF)
排除标准
- •Refusal to sign the WCF
- •End stage renal failure
- •Urgency/Emergency procedure
- •Contraindication to perform both coronary and left ventricle angiogram
- •Necessity of another vascular angiogram during coronary angiography
研究组 & 干预措施
Trans-radial access
Coronary angiography performed through trans-radial access
干预措施: Trans-radial (Other)
Trans-femoral access
Coronary angiography performed through trans-femoral access
干预措施: Trans-femoral (Other)
结局指标
主要结局
Patient radiation exposure (mGy)
时间窗: during coronary angiography
Patient radiation exposure (mGy)
次要结局
- Physician radiation exposure (in uSv)(during coronary angiography)