Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01446263
First received: September 29, 2011
Last updated: October 27, 2013
Last verified: October 2013
History of Changes
  Purpose

Increased use of radial access for cardiac catheterization is being advocated because studies have showed lower arterial access related complication rates and higher patient satisfaction as compared to femoral access. However, little is known on patients with prior coronary artery bypass graft (CABG). The RADIAL CABG Trial is a randomized-controlled trial proposed to test the hypothesis that bypass graft angiography and intervention via radial access provides lower vascular complication rates, similar contrast and equipment utilization and higher patient satisfaction when compared with transfemoral approach.


Condition Intervention Phase
Vascular Access Complication
 Procedure: Radial access versus femoral access for coronary angiography and intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Amount of contrast used [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total procedure time [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Fluoroscopy time [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma] [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Performance of ascending aortic angiography to identify patent bypass grafts [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Number of catheters and wires used [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Enrollment: 128
Study Start Date: October 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radial access Procedure: Radial access versus femoral access for coronary angiography and intervention
Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts
Active Comparator: Femoral access Procedure: Radial access versus femoral access for coronary angiography and intervention
Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts

Detailed Description:

This is a phase III, single-center, prospective, randomized trial that will compare resource utilization, clinical outcomes and patient satisfaction between radial and femoral access for patients with prior coronary artery bypass graft (CABG)surgery undergoing coronary and graft angiography and intervention. During clinically-indicated coronary angiography of patients with prior CABG, the amount resources used, radiation exposure to patients and operators, occurence of complications and patients satisfaction will be compared between the two treatment arms to determine whether compared to femoral approach radial access will result in:

  1. similar contrast utilization (primary endpoint)
  2. similar procedure time (secondary endpoint)
  3. similar fluoroscopy time (secondary endpoint)
  4. similar radiation exposure of the patient - measured as DAP [dose area product] and AK [air kerma] (secondary endpoint)
  5. similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
  6. similar number and types of catheters and guidewires used (secondary endpoint)
  7. reduction in vascular access complications (secondary endpoint)
  8. reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
  9. higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)
  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18-years
  • Prior coronary artery bypass graft surgery
  • Referred for clinically-indicated coronary and graft angiography and/or intervention
  • Able to provide informed consent

Exclusion Criteria:

  • Known pathologic Allen's test
  • Known difficulty that limits vascular access at the femoral or radial arteries
  • Age > 90
  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: NCT01446263

Locations
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Principal Investigator: Emmanouil s Brilakis, MD, PhD North Texas Veterans Healthcare System
  More Information

Publications:

Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01446263     History of Changes
Other Study ID Numbers: #11‐063
Study First Received: September 29, 2011
Last Updated: October 27, 2013
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
Radial access
Femoral access
Coronary angiography
Coronary artery bypass graft

ClinicalTrials.gov processed this record on February 27, 2015