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
  Purpose

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.


Condition Intervention
Vascular Access
Procedure: Fluoroscopy
Procedure: Active Comparator

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fluoroscopy Guided Femoral Arterial Access and the Use of Closure Devices: A Randomized Controlled Trial.

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 990
Study Start Date: March 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222430

Locations
United States, Oklahoma
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States, 73104
Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Thomas Hennebry, M.D. University of Oklahoma
Principal Investigator: Mazen S Abu-Fadel, M.D. University of Oklahoma
  More Information

Additional Information:
Publications:
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00222430     History of Changes
Other Study ID Numbers: 11854
Study First Received: September 20, 2005
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Fluoroscopy
Femoral Artery
Arterial Vascular Access

ClinicalTrials.gov processed this record on July 24, 2014