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

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial

Conditions
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Vascular Access Complication

Intervention / Treatment
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* Procedure: Radial access versus femoral access for coronary angiography and intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radial access<br> | Procedure: Radial access versus femoral access for coronary angiography and intervention<br>* Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts<br>|
| Active Comparator: Femoral access<br> | Procedure: Radial access versus femoral access for coronary angiography and intervention<br>* Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of contrast used |  | 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial access, Femoral access, Coronary angiography, Coronary artery bypass graft