Status:
COMPLETED
Randomized Endo-Vein Graft Prospective
Lead Sponsor:
VA Office of Research and Development
Conditions:
Coronary Artery Bypass Grafting
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 condui...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
1150 Patients enrolled
Trial Details
Trial ID
NCT01850082
Start Date
September 30 2013
End Date
October 30 2020
Last Update
December 15 2021
Active Locations (16)
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1
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723
2
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
3
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608
4
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125