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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Coronary artery bypass grafting (CABG) is the most common major surgical procedure in the United States with over 300,000 cases performed each year. To restore blood flow to the heart, vascular conduits from another part of the body are procured to create a bypass around critically blocked coronary arteries. The left internal thoracic artery is the conduit of choice for CABG due to its superior long-term patency. However, almost all patients referred for CABG require additional grafts to provide complete revascularization. This necessitates the harvest of other vessels, most commonly the saphenous vein which is used almost ubiquitously in contemporary CABG with an average of two vein grafts per CABG procedure. In the last 10 years, Endoscopic Vein Harvesting (EVH) has been recommended as the preferred method over the traditional open harvesting technique (OVH) because it provides a minimally invasive approach. However, more recent investigations indicate potential for reduced long-term bypass graft patency and worse clinical outcomes with EVH. The long term impact of EVH on clinical outcomes has never been investigated on a large scale using a definitive, adequately powered, prospective Randomized Controlled Trial (RCT) with long-term follow-up.

Official Title

CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial

Details

CSP #588 - REGROUP is a randomized, intent-to-treat, two-arm, parallel design, multicenter study. Cardiac Surgery Programs at Veterans Affairs Medical Centers (VAMC) with expertise in performing both EVH and OVH will be invited to participate in the study. Subjects requiring elective or urgent CABG using cardiopulmonary bypass with use of at least one SVG will be screened for enrollment using established inclusion/exclusion criteria. Enrolled Subjects will be randomized to one of the two arms (EVH or OVH) after an experienced vein harvester is identified and assigned. Intraoperative assessments will be collected and post-operative assessments will be completed 24 hours post-surgery. Additional assessments will be completed at the time of discharge or at the 30-day post-surgery date if the subject is still in the hospital. Assessment of leg wound complications will be completed at the time of discharge and at six-week post-surgery. Telephone follow-ups will occur at three-month interval post-surgery until the participating sites are decommissioned at the end of the trial period (which would be approximately 4.5 years after the site initiations). For long-term MACE outcomes, passive follow up for MACE events using VA databases (CPRS, VASQIP) will be performed centrally by the Study Chair's office for another 2 years.

Keywords

Coronary Artery Bypass Grafting Coronary artery disease CABG Coronary revascularization Endoscopic vein harvest Saphenous vein graft Graft failure

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age years 18 years or older
  • Elective or Urgent CABG-only
  • Median sternotomy approach
  • At least one coronary bypass planned using saphenous vein graft for conduit
  • Experienced EVH/OVH harvester available for procedure

You CAN'T join if...

  • Combined valve procedure planned
  • Moderate or severe valve disease (see definition of moderate/severe valve)
  • Hemodynamically unstable or in cardiogenic shock
  • Enrolled in another therapeutic or interventional study
  • Off-pump CABG procedure planned
  • Limited life expectancy < 1 year
  • History of lower extremities venous stripping or ligation
  • Inability to provide informed consent

Locations

  • VA Portland Health Care System, Portland, OR
    Portland, Oregon, 97239, United States
  • Southern Arizona VA Health Care System, Tucson, AZ
    Tucson, Arizona, 85723, United States
  • New Mexico VA Health Care System, Albuquerque, NM
    Albuquerque, New Mexico, 87108-5153, United States
  • Michael E. DeBakey VA Medical Center, Houston, TX
    Houston, Texas, 77030, United States
  • Minneapolis VA Health Care System, Minneapolis, MN
    Minneapolis, Minnesota, 55417, United States
  • Clement J. Zablocki VA Medical Center, Milwaukee, WI
    Milwaukee, Wisconsin, 53295-1000, United States
  • Louis Stokes VA Medical Center, Cleveland, OH
    Cleveland, Ohio, 44106, United States
  • Asheville VA Medical Center, Asheville, NC
    Asheville, North Carolina, 28805, United States
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
    Pittsburgh, Pennsylvania, 15240, United States
  • North Florida/South Georgia Veterans Health System, Gainesville, FL
    Gainesville, Florida, 32608, United States
  • James A. Haley Veterans' Hospital, Tampa, FL
    Tampa, Florida, 33612, United States
  • Durham VA Medical Center, Durham, NC
    Durham, North Carolina, 27705, United States
  • Miami VA Healthcare System, Miami, FL
    Miami, Florida, 33125, United States
  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
    New York, New York, 10010, United States
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
    Boston, Massachusetts, 02130, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT01850082
Study Type
Interventional
Last Updated
May 1, 2017