Radial Artery Versus Saphenous Vein Grafts in Coronary Artery Bypass Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00054847
First received: February 11, 2003
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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 Intervention
Cardiovascular Disease
Coronary Artery Disease
Procedure: saphenous vein graft
Procedure: radial artery graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CSP #474 - Radial Artery vs. Saphenous Vein Grafts in Coronary Artery Bypass Surgery (Radial Artery)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • To Compare 1-year Angiographic Patency of Radial Artery Grafts vs Saphenous Vein Grafts in Patients Undergoing Elective CABG [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary end point was angiographic graft patency at 1 year after CABG, 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 CABG 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:
  • Death [ Time Frame: Within 1 year of surgery. ] [ Designated as safety issue: No ]
  • Myocardial Infarction [ Time Frame: Within 1 year of bypass surgery ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: Within 1 year of bypass surgery ] [ Designated as safety issue: No ]

Enrollment: 751
Study Start Date: February 2003
Study Completion Date: February 2010
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Saphenous Vein Graft
Procedure: saphenous vein graft
Saphenous vein harvested from the arm is used as a conduit for CABG.
Active Comparator: Arm 2
Radial Artery
Procedure: radial artery graft
Radial artery harvested from the arm is used as a conduit for CABG.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054847

Locations
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
Investigators
Study Chair: Steven Goldman, MD Southern Arizona VA Health Care System
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00054847     History of Changes
Other Study ID Numbers: 474
Study First Received: February 11, 2003
Results First Received: January 31, 2014
Last Updated: January 31, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
CABG
cardiovascular
chronic diseases
clinical trial
heart
multi-site trial
prospective

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

ClinicalTrials.gov processed this record on April 14, 2014