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

• Sponsor: North Texas Veterans Healthcare System (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01446263
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Access Complication	Procedure: Radial access versus femoral access for coronary angiography and intervention	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Radial access	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
Active Comparator: Femoral access	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

Outcome Measures

Primary Outcome Measures

1. Amount of contrast used [24 hours]

Secondary Outcome Measures

1. Total procedure time [24 hours]

2. Fluoroscopy time [24 hours]

3. Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma] [24 hours]

4. Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices [24 hours]

5. Performance of ascending aortic angiography to identify patent bypass grafts [24 hours]

6. Number of catheters and wires used [24 hours]

7. Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding) [24 hours]

8. Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) [24 hours]

9. Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dallas VA Medical Center	Dallas	Texas	United States	75216

Sponsors and Collaborators

• North Texas Veterans Healthcare System

Investigators

• Principal Investigator: Emmanouil s Brilakis, MD, PhD, North Texas Veterans Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
• ClinicalTrials.gov Identifier: NCT01446263
• Other Study ID Numbers: #11-063
• First Posted: Oct 5, 2011
• Last Update Posted: Oct 29, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System: Radial access; Femoral access; Coronary angiography; Coronary artery bypass graft

Study Results

No Results Posted as of Oct 29, 2013