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NCT06065943: PARFEM

Ultrasound-guided In-plane Puncture of the Femoral Artery

Completed NA Last updated 15 August 2024
What this trial tests

NA trial testing Palpation and Fluoroscopy in Vessel Puncture Site Bleeding in 286 participants. Completed in 30 June 2024.

Timeline
1 July 2022
Primary endpoint
31 March 2024
30 June 2024

Quick facts

Lead sponsorWuerzburg University Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposediagnostic
Enrollment286
Start date1 July 2022
Primary completion31 March 2024
Estimated completion30 June 2024
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Wuerzburg University Hospital

Who can join

Eligibility, any sex, with Vessel Puncture Site Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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").

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Can Ultrasound-Guided in-Plane Puncture Technique Enhance the Precision of Femoral Artery Access? The Randomized PARFEM Trial.
    Voelker W, Lachmann M, Gueder G, Bayik A, et al · · 2025 · PMID 40735901 · DOI 10.1002/ccd.31733

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