Ultrasound-guided In-plane Puncture of the Femoral Artery

NCT ID: NCT06065943

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-06-30

Brief Summary

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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").

Detailed Description

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Conditions

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Vessel Puncture Site Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound guidance

Group Type ACTIVE_COMPARATOR

Ultrasound guidance

Intervention Type PROCEDURE

Vessel puncture guided by Ultrasound

Palpation and Fluoroscopy

Group Type OTHER

Palpation and Fluoroscopy

Intervention Type OTHER

Vessel puncture guided palpation and fluoroscopy only

Interventions

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Palpation and Fluoroscopy

Vessel puncture guided palpation and fluoroscopy only

Intervention Type OTHER

Ultrasound guidance

Vessel puncture guided by Ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* transfemoral catheterization

Exclusion Criteria

* acute myocardial infarction
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Würzburg, , Germany

Site Status

Countries

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Germany

References

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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 Jul 30. doi: 10.1002/ccd.31733. Online ahead of print.

Reference Type DERIVED
PMID: 40735901 (View on PubMed)

Other Identifiers

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112/19-sc

Identifier Type: -

Identifier Source: org_study_id

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