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Ultrasound-guided In-plane Puncture of the Femoral Artery

NCT06065943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2024-08-15

No results posted yet for this study

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").

Conditions

  • Vessel Puncture Site Bleeding

Interventions

OTHER

Palpation and Fluoroscopy

Vessel puncture guided palpation and fluoroscopy only

PROCEDURE

Ultrasound guidance

Vessel puncture guided by Ultrasound

Sponsors & Collaborators

  • Wuerzburg University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-03-31
Completion
2024-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065943 on ClinicalTrials.gov