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").
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
286
Vessel puncture guided palpation and fluoroscopy only
Vessel puncture guided by Ultrasound
University Hospital
Würzburg, Germany
Initial successful puncture of the common femoral artery
Analysis of rotational femoral angiography
Time frame: 1 week
Unsuccessful puncture attempts
number of unsuccessful puncture attempts
Time frame: access-phase of the procedure
Perception of pain
pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient
Time frame: Evaluated at the end of the access-phase of the procedure
accidental venipuncture
Venipuncture was recognized by backflow of pulsatile and non-arterial blood
Time frame: at the end of the access-phase of the procedure
Duration until successful puncture
Time frame between start of initial puncture and successful introduction of the guide-wire up to 1 minute
Time frame: Evaluated at the end of the access-phase of the procedure
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