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

Veterans Affairs (VA) North Texas Health Care System

Status and phase: Completed; Phase 3

Conditions: Vascular Access Complication

Treatments: Procedure: Radial access versus femoral access for coronary angiography and intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01446263

#11-063

Details and patient eligibility

About

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.

Full 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)

Enrollment: 128 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Radial access

Active Comparator group

Treatment:

Procedure: Radial access versus femoral access for coronary angiography and intervention

Femoral access

Active Comparator group

Treatment:

Procedure: Radial access versus femoral access for coronary angiography and intervention