Femoral Arterial Access With Ultrasound Trial (FAUST)

This study has been completed.
Sponsor:
Collaborators:
C. R. Bard
University of Oklahoma
Long Beach Memorial Medical Center
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00667381
First received: April 24, 2008
Last updated: October 19, 2010
Last verified: October 2010
Results First Received: September 27, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Vascular Access Complications
Cardiac Catheterization
Peripheral Vascular Disease
Intervention: Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between April 2008 and February 2009, 1014 patients presenting for elective or urgent (but not emergent) cardiac or peripheral catheterization were enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
10 patients (6 control, 4 US) were excluded after randomization but before procedure for no longer meeting the inclusion criteria, including cancellation of the procedure, lack of a dual-trained operator, or change in access site. Baseline and procedural data were not recorded in this group, and these were not included in any analysis.

Reporting Groups
  Description
Control The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
Ultrasound Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.

Participant Flow:   Overall Study
    Control     Ultrasound  
STARTED     501     503  
COMPLETED     501     503  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
Ultrasound Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.
Total Total of all reporting groups

Baseline Measures
    Control     Ultrasound     Total  
Number of Participants  
[units: participants]
  501     503     1004  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     255     273     528  
>=65 years     246     230     476  
Age  
[units: years]
Mean ± Standard Deviation
  64.2  ± 11.4     63.5  ± 12.4     63.8  ± 11.9  
Gender  
[units: participants]
     
Female     135     132     267  
Male     366     371     737  
Region of Enrollment  
[units: participants]
     
United States     501     503     1004  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography   [ Time Frame: Immediately, during procedure. ]

2.  Secondary:   Time to Successful Sheath Insertion.   [ Time Frame: Immediate ]

3.  Secondary:   Number of Patients With Accidental Femoral Venipunctures.   [ Time Frame: Immediate ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Number of Patients With Accidental Femoral Venipunctures.
Measure Description

Number of patients with any femoral venipunctures where an insertion was not intended, i.e. excluding patients with planned right heart catheterization. Multiple accidental venipunctures were not double counted.

Number of attempts and venipunctures were not recorded in 1 control and 1 ultrasound patient, so the denominator is 500 control patients and 502 ultrasound patients.

Time Frame Immediate  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.
Ultrasound Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.

Measured Values
    Control     Ultrasound  
Number of Participants Analyzed  
[units: participants]
  500     502  
Number of Patients With Accidental Femoral Venipunctures.  
[units: participants]
  79     12  

No statistical analysis provided for Number of Patients With Accidental Femoral Venipunctures.



4.  Secondary:   Number of Participants With Vascular Complications   [ Time Frame: Immediate and up to 1 month after procedure. ]

5.  Other Pre-specified:   Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations   [ Time Frame: At angiogram analysis ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Arnold Seto
Organization: University of California, Irvine
phone: 714-456-6699
e-mail: aseto@uci.edu


Publications of Results:

Responsible Party: Arnold Seto, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00667381     History of Changes
Other Study ID Numbers: HS# 2007-5989
Study First Received: April 24, 2008
Results First Received: September 27, 2010
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board