Ultrasound-guided In-plane Puncture of the Femoral Artery (PARFEM)

Wuerzburg University Hospital

Status: Completed

Conditions: Vessel Puncture Site Bleeding

Treatments: Other: Palpation and Fluoroscopy; Procedure: Ultrasound guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT06065943

112/19-sc

Details and patient eligibility

About

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").

Enrollment: 286 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• transfemoral catheterization

Exclusion criteria

• acute myocardial infarction

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

Ultrasound guidance

Active Comparator group

Treatment:

Procedure: Ultrasound guidance

Palpation and Fluoroscopy

Other group

Treatment:

Other: Palpation and Fluoroscopy