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OpenTrials
Completed

NCT Number: NCT06065943

Ultrasound-guided In-plane Puncture of the Femoral Artery

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").

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Würzburg, 97080, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • transfemoral catheterization

Exclusion criteria

  • acute myocardial infarction

Treatment and study plan

Palpation and Fluoroscopy

Other

Vessel puncture guided palpation and fluoroscopy only

Ultrasound guidance

Procedure

Vessel puncture guided by Ultrasound

Primary outcomes

  1. Initial successful puncture of the common femoral artery

    Time frame: 1 week

    Analysis of rotational femoral angiography

Secondary outcomes

  1. Unsuccessful puncture attempts

    Time frame: access-phase of the procedure

    number of unsuccessful puncture attempts

  2. Perception of pain

    Time frame: Evaluated at the end of the access-phase of the procedure

    pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient

  3. accidental venipuncture

    Time frame: at the end of the access-phase of the procedure

    Venipuncture was recognized by backflow of pulsatile and non-arterial blood

  4. Duration until successful puncture

    Time frame: Evaluated at the end of the access-phase of the procedure

    Time frame between start of initial puncture and successful introduction of the guide-wire up to 1 minute

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

Department of Cardiology Wuerzburg University

Acronym: PARFEM

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2023
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.