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Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00054847
Recruitment Status : Completed
First Posted : February 13, 2003
Results First Posted : March 14, 2014
Last Update Posted : May 5, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
VA patients with coronary artery disease and who have agreed to undergo coronary artery bypass graft surgery would be randomized to receive either radial artery or saphenous vein to the study vessel. The primary outcome variable is graft patency at one year.

Condition or disease Intervention/treatment
Cardiovascular Disease Coronary Artery Disease Procedure: saphenous vein graft Procedure: radial artery graft

  Show Detailed Description

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
Primary Completion Date : February 2009
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Death [ Time Frame: Within 1 year of surgery. ]
  2. Myocardial Infarction [ Time Frame: Within 1 year of bypass surgery ]
  3. Stroke [ Time Frame: Within 1 year of bypass surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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)

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): 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
Sponsors and Collaborators
VA Office of Research and Development
Study Chair: Steven Goldman, MD Southern Arizona VA Health Care System


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00054847     History of Changes
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

Keywords provided by VA Office of Research and Development:
chronic diseases
clinical trial
multi-site trial

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases