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

Primary Purpose

Vessel Puncture Site Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Palpation and Fluoroscopy
Ultrasound guidance
Sponsored by
Wuerzburg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vessel Puncture Site Bleeding focused on measuring ultrasound guided puncture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: transfemoral catheterization Exclusion Criteria: acute myocardial infarction

Sites / Locations

  • University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Ultrasound guidance

Palpation and Fluoroscopy

Arm Description

Outcomes

Primary Outcome Measures

Initial successful puncture of the common femoral artery
Analysis of rotational femoral angiography

Secondary Outcome Measures

Unsuccessful puncture attempts
number of unsuccessful puncture attempts
Perception of pain
pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient
accidental venipuncture
Venipuncture was recognized by backflow of pulsatile and non-arterial blood
Duration until successful puncture

Full Information

First Posted
September 5, 2023
Last Updated
September 26, 2023
Sponsor
Wuerzburg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06065943
Brief Title
Ultrasound-guided In-plane Puncture of the Femoral Artery
Acronym
PARFEM
Official Title
Department of Cardiology Wuerzburg University
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuerzburg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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").

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vessel Puncture Site Bleeding
Keywords
ultrasound guided puncture

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guidance
Arm Type
Active Comparator
Arm Title
Palpation and Fluoroscopy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Palpation and Fluoroscopy
Intervention Description
Vessel puncture guided palpation and fluoroscopy only
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guidance
Intervention Description
Vessel puncture guided by Ultrasound
Primary Outcome Measure Information:
Title
Initial successful puncture of the common femoral artery
Description
Analysis of rotational femoral angiography
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Unsuccessful puncture attempts
Description
number of unsuccessful puncture attempts
Time Frame
access-phase of the procedure
Title
Perception of pain
Description
pain scale between 0 (no pain) and 10 (maximum pain) graded by the patient
Time Frame
Evaluated at the end of the access-phase of the procedure
Title
accidental venipuncture
Description
Venipuncture was recognized by backflow of pulsatile and non-arterial blood
Time Frame
at the end of the access-phase of the procedure
Title
Duration until successful puncture
Time Frame
time frame between start of initial puncture and successful introduction of the guide-wire

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: transfemoral catheterization Exclusion Criteria: acute myocardial infarction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wolfram Voelker, MD
Phone
01714170339
Email
voelker_w@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Gül Güder, MD
Phone
0049-931-201-0
Email
gueder_g@ukw.de
Facility Information:
Facility Name
University Hospital
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfram Voelker
Phone
01714170339
Email
voelker_w@ukw.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound-guided In-plane Puncture of the Femoral Artery

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