Vascular Access Complication
Conditions
Keywords
Radial access, Femoral access, Coronary angiography, Coronary artery bypass graft
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)
Interventions
PROCEDURERadial 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
Sponsors
North Texas Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of contrast used | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Total procedure time | 24 hours |
| Fluoroscopy time | 24 hours |
| Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices | 24 hours |
| Performance of ascending aortic angiography to identify patent bypass grafts | 24 hours |
| Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma] | 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 |
| Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure | 24 hours |
| Number of catheters and wires used | 24 hours |
Countries
United States
Outcome results
None listed