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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").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guidance | Active Comparator |
| |
| Palpation and Fluoroscopy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palpation and Fluoroscopy | Other | Vessel puncture guided palpation and fluoroscopy only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial successful puncture of the common femoral artery | Analysis of rotational femoral angiography | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Unsuccessful puncture attempts | number of unsuccessful puncture attempts | access-phase of the procedure |
| Perception of pain | pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Würzburg | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40735901 | Derived | 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. |
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| Ultrasound guidance | Procedure | Vessel puncture guided by Ultrasound |
|
| Evaluated at the end of the access-phase of the procedure |
| accidental venipuncture | Venipuncture was recognized by backflow of pulsatile and non-arterial blood | at the end of the access-phase of the procedure |
| Duration until successful puncture | Time frame between start of initial puncture and successful introduction of the guide-wire up to 1 minute | Evaluated at the end of the access-phase of the procedure |