Ultrasound-guided In-plane Puncture of the Femoral Artery

NCT06065943 | Completed

• 1 other identifier: 112/19-sc
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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").

Conditions

Vessel Puncture Site Bleeding

Keywords

ultrasound guided puncture

Outcome Measures

Primary Outcomes (1)

• Initial successful puncture of the common femoral artery

  Analysis of rotational femoral angiography

  1 week

Secondary Outcomes (4)

• 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 Arms (2)

Ultrasound guidance

ACTIVE COMPARATOR

Procedure: Ultrasound guidance

Palpation and Fluoroscopy

OTHER

Other: Palpation and Fluoroscopy

Interventions

Palpation and Fluoroscopy OTHER

Vessel puncture guided palpation and fluoroscopy only

Palpation and Fluoroscopy

Ultrasound guidance PROCEDURE

Vessel puncture guided by Ultrasound

Ultrasound guidance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• transfemoral catheterization

You may not qualify if:

• acute myocardial infarction

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Hospital

Würzburg, 97080, Germany

Location

Related Publications (1)

• Voelker W, Lachmann M, Gueder G, Bayik A, Heinrichs M, Kickuth R, Bauer WR, Lengenfelder B, Nordbeck P, Frantz S, Stork S. Can Ultrasound-Guided in-Plane Puncture Technique Enhance the Precision of Femoral Artery Access? The Randomized PARFEM Trial. Catheter Cardiovasc Interv. 2025 Oct;106(4):2252-2262. doi: 10.1002/ccd.31733. Epub 2025 Jul 30.

  PMID: 40735901 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: October 4, 2023
• Study Start: July 1, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)