Femoral Arterial Access With Ultrasound Trial

NCT00667381 | Completed Results

• 1 other identifier: HS# 2007-5989
• Study Type: interventional
• Target: 1,014
• Locations: 1 country
• Sites: 4

Brief Summary

This study is designed to evaluate the routine use of vascular ultrasound as an aid for proper placement of a femoral arterial sheath during cardiac catheterization and peripheral arterial angiography.

Conditions

Vascular Access Complications; Cardiac Catheterization; Peripheral Vascular Disease

Keywords

Ultrasound guidance; Vascular access; Vascular complications

Outcome Measures

Primary Outcomes (1)

• Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography

  Femoral angiography was performed in 490 control patients and 499 ultrasound patients. In 11 control and 4 ultrasound patients, femoral angiography was either not performed or was inadequate for analysis. These patients were excluded from the primary outcome analysis but included for other analyses. Successful common femoral artery cannulation was defined as sheath insertion above the bifurcation of the common femoral artery and below the origin of the inferior epigastric artery. Unsuccessful sheath insertion was defined as sheath insertion outside of these markers.

  Immediately, during procedure.

Secondary Outcomes (3)

• Time to Successful Sheath Insertion.

  Immediate

• Number of Patients With Accidental Femoral Venipunctures.

  Immediate

• Number of Participants With Vascular Complications

  Immediate and up to 1 month after procedure.

Other Outcomes (1)

• Number of Patients With Successful Common Femoral Artery Placement, Among Those Patients With High Femoral Artery Bifurcations

  At angiogram analysis

Study Arms (2)

Control

NO INTERVENTION

The combination of anatomic landmarks and fluoroscopic localization of the femoral head will be used to guide femoral arterial access.

Ultrasound

EXPERIMENTAL

Patients randomized to Ultrasound will have anatomic landmarks checked and real-time ultrasound guidance to aid femoral arterial access.

Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine)

Interventions

Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine) DEVICE

Real-time ultrasound guidance will be used to aid in femoral artery cannulation. This will occur with a 7 MHz ultrasound probe covered with a sterile cover.

Also known as: Site-Rite 5 or 6 ultrasound machine.

Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 and over
• Patients undergoing left heart catheterization or peripheral arterial angiography from the retrograde femoral approach
• Willingness and ability to sign consent form
• Scheduled to have procedure performed by operator trained in the ultrasound technique

You may not qualify if:

• Access from a site other than the common femoral artery
• Nonpalpable femoral pulses
• Creatinine \> 3.0 mg/dl, unless already on dialysis
• Prisoners
• Pregnant women
• Unable or refusal to sign consent form
• Patients undergoing emergent cardiac catheterization for ST segment elevation myocardial infarction or unstable acute coronary syndrome
• Equipment unavailable

Sponsors & Collaborators

• University of California, Irvine: lead
• C. R. Bard: collaborator
• University of Oklahoma: collaborator
• US Department of Veterans Affairs: collaborator
• Long Beach Memorial Medical Center: collaborator

Study Sites (4)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.jcin.2010.04.015.

  PMID: 20650437 RESULT

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Arnold Seto
• Organization: University of California, Irvine

aseto@uci.edu

714-456-6699

Study Officials

• Arnold H Seto, MD, MPA

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Morton Kern, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Mazen Abu-Fadel, MD

  Oklahoma Veteran's Administration Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: April 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: November 16, 2010
• Results First Posted: November 16, 2010

Record last verified: 2010-10

Locations

US (4)