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.

Study Overview

• Status: Completed
• Conditions: Vascular Access
• Intervention / Treatment: Procedure: Active Comparator; Procedure: Fluoroscopy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 990
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Medical Center
    • Oklahoma City, Oklahoma, United States, 73104
      • Veterans Affairs Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Usual standard coronary angiographic procedure	Procedure: Active Comparator; Standard coronary angiography technique; no fluoroscopic assistance
Experimental: B; Fluoroscopy-guided coronary angiography	Procedure: Fluoroscopy; Use of fluoroscopy during arterial insertion of coronary catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prediction of ability to use femoral artery closure device based on angiographic data of the femoral artery from fluoroscopy arm versus traditional technique arm.	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare the incidence of known major side effects of femoral artery puncture between the two methods of access	24 hours
Compare the time and number of attempts needed to obtain arterial access between the two groups of patients.	Intraprocedural
Compare the ability to puncture the common femoral artery using fluoroscopy vs. anatomical landmarks among different levels of trainees (cardiology fellows) and attending cardiologists.	Intraprocedural
Assess whether fluoroscopic guidance is a superior method to obtain access and thus should be used as a training technique for cardiology fellows.	End of study analysis

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Thomas Hennebry, M.D., University of Oklahoma; Principal Investigator: Mazen S Abu-Fadel, M.D., University of Oklahoma

Publications and helpful links

General Publications

• 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. doi: 10.1002/ccd.22174.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: September 20, 2005
• First Submitted That Met QC Criteria: September 20, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Estimate): March 28, 2012
• Last Update Submitted That Met QC Criteria: March 27, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Fluoroscopy; Femoral Artery; Arterial Vascular Access
• Other Study ID Numbers: 11854 (Other Identifier: University of California, San Francisco)