RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial (RADIAL-CABG)
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ClinicalTrials.gov Identifier: NCT01446263 |
Recruitment Status
:
Completed
First Posted
: October 5, 2011
Last Update Posted
: October 29, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vascular Access Complication | Procedure: Radial access versus femoral access for coronary angiography and intervention | Phase 3 |
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:
- similar contrast utilization (primary endpoint)
- similar procedure time (secondary endpoint)
- similar fluoroscopy time (secondary endpoint)
- similar radiation exposure of the patient - measured as DAP [dose area product] and AK [air kerma] (secondary endpoint)
- similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
- similar number and types of catheters and guidewires used (secondary endpoint)
- reduction in vascular access complications (secondary endpoint)
- reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
- higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
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
|
- Amount of contrast used [ Time Frame: 24 hours ]
- Total procedure time [ Time Frame: 24 hours ]
- Fluoroscopy time [ Time Frame: 24 hours ]
- Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma] [ Time Frame: 24 hours ]
- Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices [ Time Frame: 24 hours ]
- Performance of ascending aortic angiography to identify patent bypass grafts [ Time Frame: 24 hours ]
- Number of catheters and wires used [ Time Frame: 24 hours ]
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding) [ Time Frame: 24 hours ]
- Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) [ Time Frame: 24 hours ]
- Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446263
United States, Texas | |
Dallas VA Medical Center | |
Dallas, Texas, United States, 75216 |
Principal Investigator: | Emmanouil s Brilakis, MD, PhD | North Texas Veterans Healthcare System |
Publications of Results:
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 |
First Posted: | October 5, 2011 Key Record Dates |
Last Update Posted: | October 29, 2013 |
Last Verified: | October 2013 |
Keywords provided by Emmanouil Brilakis, North Texas Veterans Healthcare System:
Radial access Femoral access Coronary angiography Coronary artery bypass graft |