Femoral Arterial Access With Ultrasound Trial - Study Results

Femoral Arterial Access With Ultrasound Trial (FAUST)

This study has been completed.

Study NCT00667381 Information provided by University of California, Irvine

First Received on April 24, 2008. Last Updated on October 19, 2010 History of Changes

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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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.

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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

Number of Patients With Accidental Femoral Venipunctures. [ Time Frame: Immediate ]

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4. Secondary:

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

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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
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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:

Seto AH, Abu-Fadel MS, Sparling JM, Zacharias SJ, Daly TS, Harrison AT, Suh WM, Vera JA, Aston CE, Winters RJ, Patel PM, Hennebry TA, Kern MJ. Real-time ultrasound guidance facilitates femoral arterial access and reduces vascular complications: FAUST (Femoral Arterial Access With Ultrasound Trial). JACC Cardiovasc Interv. 2010 Jul;3(7):751-8.

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