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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Vascular Access Complication	Procedure: Radial access versus femoral access for coronary angiography and intervention	Phase 3

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)

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Amount of contrast used [ Time Frame: 24 hours ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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 (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.

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
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