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
About this trial
This is an interventional diagnostic trial for Vessel Puncture Site Bleeding focused on measuring ultrasound guided puncture
Eligibility Criteria
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
NCT ID
NCT06065943
First Posted
September 5, 2023
Last Updated
September 26, 2023
Sponsor
Wuerzburg University Hospital
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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