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

September 29, 2011
October 27, 2013
October 2011
April 2013   (final data collection date for primary outcome measure)
Amount of contrast used [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01446263 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial

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.

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)
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Vascular Access Complication
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: Radial access
    Intervention: Procedure: Radial access versus femoral access for coronary angiography and intervention
  • Active Comparator: Femoral access
    Intervention: Procedure: Radial access versus femoral access for coronary angiography and intervention
Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A Randomized Comparison of the Transradial and Transfemoral Approaches for Coronary Artery Bypass Graft Angiography and Intervention (the RADIAL-CABG Trial). JACC Cardiovasc Interv. 2013 Oct 10. doi:pii: S1936-8798(13)01355-1. 10.1016/j.jcin.2013.08.004. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
128
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01446263
#11‐063
Yes
Emmanouil Brilakis, North Texas Veterans Healthcare System
North Texas Veterans Healthcare System
Not Provided
Principal Investigator: Emmanouil s Brilakis, MD, PhD North Texas Veterans Healthcare System
North Texas Veterans Healthcare System
October 2013

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