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临床试验/NCT06065943
NCT06065943已完成不适用

Department of Cardiology Wuerzburg University

Wuerzburg University Hospital2 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2022年7月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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