NCT01446263

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: North Texas Veterans Healthcare System · Federal
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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)

Conditions

• Vascular Access Complication

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-10-05
• Last updated: 2013-10-29

Locations

1 site across 1 country: United States