Department of Cardiology Wuerzburg University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 2
- 主要终点
- Initial successful puncture of the common femoral artery
研究概览
简要总结
In Germany almost 1 million cardiac catheterizations are performed each year. These procedures can be done either by a transradial or a transfemoral approach. Today, the transradial approach is the recommended default strategy. Nevertheless, transfemoral access ist still frequently used. The main draw-back of a transfemoral approach are potential access site complications, which can sometimes be life-threatening. To reduce vascular complications ultrasound guided vessel puncture may be helpful.
In the "Ultrasound guided puncture of the femoral artery"-Study (US-Parfem) an optimized method of ultrasound guided femoral puncture will be evaluated. In this randomized study the new puncture technique combining ultrasound and fluoroscopy will be compared with the conventional method guided by vessel palpation and fluoroscopy. Primary endpoint of the study is the rate of primary successful puncture of the femoral common artery above the bifurcation and below the inguinal ligament ("first success rate").
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •transfemoral catheterization
排除标准
- •acute myocardial infarction
结局指标
主要结局
Initial successful puncture of the common femoral artery
时间窗: 1 week
Analysis of rotational femoral angiography
次要结局
- Unsuccessful puncture attempts(access-phase of the procedure)
- Perception of pain(Evaluated at the end of the access-phase of the procedure)
- accidental venipuncture(at the end of the access-phase of the procedure)
- Duration until successful puncture(Evaluated at the end of the access-phase of the procedure)
