Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery
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ClinicalTrials.gov Identifier: NCT00054847 |
Recruitment Status :
Completed
First Posted : February 13, 2003
Results First Posted : March 14, 2014
Last Update Posted : May 5, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cardiovascular Disease Coronary Artery Disease | Procedure: saphenous vein graft Procedure: radial artery graft | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 733 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery) |
Study Start Date : | February 2003 |
Actual Primary Completion Date : | February 2009 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Saphenous Vein Graft
Saphenous Vein Graft
|
Procedure: saphenous vein graft
Saphenous vein harvested from the arm is used as a conduit for CABG. |
Active Comparator: Radial Artery Graft
Radial Artery Graft
|
Procedure: radial artery graft
Radial artery harvested from the arm is used as a conduit for CABG. |
- To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery. [ Time Frame: 1 year ]The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.
- Death [ Time Frame: Within 1 year of surgery. ]
- Myocardial Infarction [ Time Frame: Within 1 year of bypass surgery ]
- Stroke [ Time Frame: Within 1 year of bypass surgery ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients needing coronary artery bypass grafts.
Exclusion Criteria:
- Patients who require only a single vessel bypass and in whom the internal mammary artery will be used for that graft
- Patients with previous stripping and ligation of saphenous veins and in whom no venous conduit is available for bypass
- Patients with Raynaud's symptoms
- Patients who have a creatinine above 2.0 mg/dL or require hemodialysis
- Patients with a positive Allen test
- Patients with cardiogenic shock
- Patients who are unable to give consent
- Patients allergic to contrast material
- Patients undergoing repeat CABG or any form of robotic surgery
- Patients who do not have full use of both arms
- Patients who are pregnant
- Patients with neurologic or musculoskeletal disease affecting the arm
- Patients who refuse to participate
- Patient requires any concomitant valve operation in the mitral, aortic, or pulmonary position. Isolated tricuspid annuloplasty is acceptable, but tricuspid valve replacement excludes the patient from consideration.
- Patient requires concomitant Dor or Maze procedure
- Patient is in another research study
- No suitable radial target (there is no non-LAD vessel with a >70% stenosis)

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): NCT00054847
United States, Alabama | |
VA Medical Center, Birmingham | |
Birmingham, Alabama, United States, 35233 | |
United States, Arizona | |
Southern Arizona VA Health Care System | |
Tucson, Arizona, United States, 85723 | |
United States, Arkansas | |
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock | |
No. Little Rock, Arkansas, United States, 72114-1706 | |
United States, Illinois | |
Edward Hines, Jr. VA Hospital | |
Hines, Illinois, United States, 60141-5000 | |
United States, Louisiana | |
Southeast Veterans Healthcare System, New Orleans | |
New Orleans, Louisiana, United States, 70112 | |
United States, Massachusetts | |
VA Boston Healthcare System, Brockton Campus | |
Brockton, Massachusetts, United States, 02301 | |
United States, Michigan | |
VA Ann Arbor Healthcare System | |
Ann Arbor, Michigan, United States, 48113 | |
United States, Minnesota | |
VA Medical Center, Minneapolis | |
Minneapolis, Minnesota, United States, 55417 | |
United States, New Mexico | |
New Mexico VA Health Care System, Albuquerque | |
Albuquerque, New Mexico, United States, 87108-5153 | |
United States, Texas | |
Michael E. DeBakey VA Medical Center (152) | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | |
Richmond, Virginia, United States, 23249 |
Study Chair: | Steven Goldman, MD | Southern Arizona VA Health Care System |
Responsible Party: | US Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00054847 |
Other Study ID Numbers: |
474 |
First Posted: | February 13, 2003 Key Record Dates |
Results First Posted: | March 14, 2014 |
Last Update Posted: | May 5, 2014 |
Last Verified: | April 2014 |
CABG cardiovascular chronic diseases clinical trial |
heart multi-site trial prospective |
Cardiovascular Diseases Coronary Artery Disease Coronary Disease Myocardial Ischemia |
Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |