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Fluoroscopy Guided Femoral Arterial Access

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00222430
First received: September 20, 2005
Last updated: March 27, 2012
Last verified: March 2012

September 20, 2005
March 27, 2012
March 2005
July 2006   (final data collection date for primary outcome measure)
Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00222430 on ClinicalTrials.gov Archive Site
  • Compare the incidence of known major side effects of femoral artery puncture between the two methods of access [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Compare the time and number of attempts needed to obtain arterial access between the two groups of patients. [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
  • Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists. [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
  • Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows. [ Time Frame: End of study analysis ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Fluoroscopy Guided Femoral Arterial Access
Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices: A Randomized Controlled Trial.

The purpose of this study is to compare the use of fluoroscopic guidance, (a commonly used X-ray technique), with the traditional approach, (where the doctors feel for the strongest pulse), to obtain access to the blood vessel in the groin. These two methods are being compared to assess which is faster, safer and more often allows your physician to use an "arterial closure device," a small suture or plug applied at the end of the angiogram where the needle enters your blood vessel if he/she chooses.

Design: A prospective, randomized, controlled clinical trial to study the effectiveness of applying fluoroscopy guided femoral artery access in the cardiac catheterization lab and its effect on the usage of FDA approved femoral artery closure devices. This trial will randomize patients between fluoroscopy guided femoral artery access or femoral artery access using the usual anatomic landmarks and will then study the difference in the ability to use closure devices on the access site.

Purpose: To establish the safety and efficacy of using fluoroscopic assistance to allow access of the common femoral artery rather than its branches and thus increase the ability to use closure devices.

Enrollment: An approximate enrollment of up to 1000 patients (all patients randomized) who will be undergoing cardiac catheterization and who meet all the eligibility criteria at OUMC and VAMC in Oklahoma City.

Duration: The study will be conducted over approximately one year.

Primary Endpoint: Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.

Secondary Endpoints:

  1. Compare the incidence of known major side effects of femoral artery puncture between the two methods of access
  2. Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.
  3. Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.
  4. Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.

Analytical Subset: Intention-to-treat sample

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vascular Access
  • Procedure: Fluoroscopy
    Use of fluoroscopy during arterial insertion of coronary catheter
  • Procedure: Active Comparator
    Standard coronary angiography technique; no fluoroscopic assistance
  • Active Comparator: A
    Usual standard coronary angiographic procedure
    Intervention: Procedure: Active Comparator
  • Experimental: B
    Fluoroscopy-guided coronary angiography
    Intervention: Procedure: Fluoroscopy
Abu-Fadel MS, Sparling JM, Zacharias SJ, Aston CE, Saucedo JF, Schechter E, Hennebry TA. Fluoroscopy vs. traditional guided femoral arterial access and the use of closure devices: a randomized controlled trial. Catheter Cardiovasc Interv. 2009 Oct 1;74(4):533-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
990
July 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 and over.
  • Patients undergoing elective or urgent left heart cath from the femoral approach.
  • Willingness to participate and sign the consent form.

Exclusion Criteria:

  • Access from site other than the common femoral artery.
  • Creatinine >= 3.0mg/dl.
  • Graft in the common femoral artery or other surgeries at that site that might have changed the anatomy of the groin.
  • Unable or refusal to sign a consent form.
  • Patients from the Department of Corrections.
  • Pregnant Women
  • Undetectable femoral artery pulse.
  • Patients undergoing emergent cardiac catheterization for ST elevation MI or unstable ACS.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00222430
11854
No
University of Oklahoma
University of Oklahoma
Not Provided
Principal Investigator: Thomas Hennebry, M.D. University of Oklahoma
Principal Investigator: Mazen S Abu-Fadel, M.D. University of Oklahoma
University of Oklahoma
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP