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

Vascular Access Complication Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01446263
Study type Interventional
Source North Texas Veterans Healthcare System
Contact
Status Completed
Phase Phase 3
Start date October 2011
Completion date April 2013
View Details
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