Department of Cardiology Wuerzburg University
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vessel Puncture Site Bleeding
- Sponsor
- Wuerzburg University Hospital
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Initial successful puncture of the common femoral artery
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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").
Investigators
Eligibility Criteria
Inclusion Criteria
- •transfemoral catheterization
Exclusion Criteria
- •acute myocardial infarction
Outcomes
Primary Outcomes
Initial successful puncture of the common femoral artery
Time Frame: 1 week
Analysis of rotational femoral angiography
Secondary Outcomes
- 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)