Transradial Approach [LEft vs Right] aNd Procedural Times During Percutaneous Coronary Procedures: TALENT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,540
- 试验地点
- 2
- 主要终点
- Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients
研究概览
简要总结
Transradial approach of cardiac catheterization is a common alternative to transfemoral access for diagnostic coronary angiography and percutaneous coronary interventions (PCI). The transradial approach reduces access site bleeding complications and the procedural discomfort of the patients. Transradial procedures may be performed by cannulation of the right or left radial artery and at present, the choice of the right or left radial artery depends largely on the operator' s preference.
The aim of this study is to evaluate safety and efficacy of transradial approach comparing the right radial versus the left radial approach in coronary diagnostic and interventional procedures.
The investigators will enroll consecutively for 12 months all patients who undergo to diagnostic or interventional procedures through trans radial approach in two Italian centers (Casilino Policlinic, Catholic University-Rome).
Primary end point of the study is the fluoroscopy time and the radiation dose adsorbed by the patients. Secondary end-points are: contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.
The investigators pre-specified a sub-study in patients older than 75 years old with the same end-points.
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
- •All patients who undergo to diagnostic or interventional procedures
排除标准
- •Previous coronary artery by-pass
- •Acute myocardial infarction with ST segment elevation myocardial infarction
- •Cardiogenic shock
- •Ischemic Allen Test
结局指标
主要结局
Primary end point of the study is the fluoroscopy time of the procedure and the radiation dose adsorbed by the patients
时间窗: 7 days
次要结局
- Contrast amount, time to obtain the first angiography, procedural shift rate, number of catheters employed, major complications.(7 days)
