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

Phase 3

Completed

• Conditions: Vascular Access Complication
• Interventions: Procedure: Radial access versus femoral access for coronary angiography and intervention

• Registration Number: NCT01446263
• Lead Sponsor: North Texas Veterans Healthcare System

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.

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 Timeline

• Study First Submitted: 2011-09-29
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-27
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral access	Radial access versus femoral access for coronary angiography and intervention	-
Radial access	Radial access versus femoral access for coronary angiography and intervention	-

Primary Outcome Measures

Name	Time	Method
Amount of contrast used	24 hours

Secondary Outcome Measures

Name	Time	Method
Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]	24 hours
Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure	24 hours
Total procedure time	24 hours
Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices	24 hours
Number of catheters and wires used	24 hours
Fluoroscopy time	24 hours
Performance of ascending aortic angiography to identify patent bypass grafts	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

Trial Locations

Locations (1)

Dallas VA Medical Center; 🇺🇸 Dallas, Texas, United States