Femoral Arterial Access With Ultrasound Trial (FAUST)
This study has been completed.
Sponsor:
University of California, Irvine
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
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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
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
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
| 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 ] |
| 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 ] |