Clinical trial NCT01446263: RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
Official title: A Randomized Comparison of RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vascular Access Complication
Keywords: Radial access
Femoral access
Coronary angiography
Coronary artery bypass graft
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2011-10-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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)

Eligibility criteria: 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

Primary outcomes:
measure: Amount of contrast used
timeFrame: 24 hours
Secondary outcomes:
measure: Total procedure time
timeFrame: 24 hours
measure: Fluoroscopy time
timeFrame: 24 hours
measure: Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma]
timeFrame: 24 hours
measure: Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices
timeFrame: 24 hours
measure: Performance of ascending aortic angiography to identify patent bypass grafts
timeFrame: 24 hours
measure: Number of catheters and wires used
timeFrame: 24 hours
measure: Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding)
timeFrame: 24 hours
measure: Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction)
timeFrame: 24 hours
measure: Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Emmanouil s Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michael TT, Alomar M, Papayannis A, Mogabgab O, Patel VG, Rangan BV, Luna M, Hastings JL, Grodin J, Abdullah S, Banerjee S, Brilakis ES. A randomized comparison of the transradial and transfemoral approaches for coronary artery bypass graft angiography and intervention: the RADIAL-CABG Trial (RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention). JACC Cardiovasc Interv. 2013 Nov;6(11):1138-44. doi: 10.1016/j.jcin.2013.08.004. Epub 2013 Oct 16.