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Clinical Trials/NCT06065943
NCT06065943
Completed
Not Applicable

Department of Cardiology Wuerzburg University

Wuerzburg University Hospital1 site in 1 country286 target enrollmentJuly 1, 2022

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").

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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