RADIAL Versus Femoral Access for Coronary Artery Bypass Graft Angiography and Intervention (RADIAL-CABG) Trial (RADIAL-CABG)
This study has been completed.
Sponsor:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01446263
First Posted: October 5, 2011
Last Update Posted: October 29, 2013
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Vascular Access Complication | Procedure: Radial access versus femoral access for coronary angiography and intervention | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Emmanouil Brilakis, North Texas Veterans Healthcare System:
Primary Outcome Measures:
- Amount of contrast used [ Time Frame: 24 hours ]
Secondary Outcome Measures:
- Total procedure time [ Time Frame: 24 hours ]
- Fluoroscopy time [ Time Frame: 24 hours ]
- Radiation exposure of the patients measured as DAP [dose area product] and AK [air kerma] [ Time Frame: 24 hours ]
- Radiation exposure of the operators as measured as AK using portable radiation dose measuring devices [ Time Frame: 24 hours ]
- Performance of ascending aortic angiography to identify patent bypass grafts [ Time Frame: 24 hours ]
- Number of catheters and wires used [ Time Frame: 24 hours ]
- Vascular access complications (hematoma, aneurysm,pseudo-aneurysm, arterio-venous fistula formation, dissection, limb ischemia, bleeding) [ Time Frame: 24 hours ]
- Overall Complications (vascular access complications, injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) [ Time Frame: 24 hours ]
- Patient satisfaction, as measured by questionnaire administered 24 hours after the procedure [ Time Frame: 24 hours ]
| Enrollment: | 128 |
| Study Start Date: | October 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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:
- similar contrast utilization (primary endpoint)
- similar procedure time (secondary endpoint)
- similar fluoroscopy time (secondary endpoint)
- similar radiation exposure of the patient - measured as DAP [dose area product] and AK [air kerma] (secondary endpoint)
- similar radiation exposure of the operators using portable radiation dose measuring devices (secondary endpoint)
- similar number and types of catheters and guidewires used (secondary endpoint)
- reduction in vascular access complications (secondary endpoint)
- reduction in overall complications (vascular access complications,injury, bleeding, death, emergency coronary bypass surgery, stroke, acute myocardial infarction) (secondary endpoint)
- higher patient satisfaction as measured by standardized survey 24-hours after the procedure (secondary endpoint)
Eligibility
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446263
Locations
| United States, Texas | |
| 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 |
More Information
Publications:
| Responsible Party: | Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01446263 History of Changes |
| Other Study ID Numbers: |
#11‐063 |
| First Submitted: | September 29, 2011 |
| First Posted: | October 5, 2011 |
| Last Update Posted: | October 29, 2013 |
| Last Verified: | October 2013 |
Keywords provided by Emmanouil Brilakis, North Texas Veterans Healthcare System:
|
Radial access Femoral access Coronary angiography Coronary artery bypass graft |