Randomized Endo-Vein Graft Prospective (REGROUP)
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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: NCT01850082 |
Recruitment Status :
Completed
First Posted : May 9, 2013
Last Update Posted : December 3, 2020
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Bypass Grafting | Procedure: Vein Harvesting Procedures | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial |
Actual Study Start Date : | September 30, 2013 |
Actual Primary Completion Date : | September 30, 2020 |
Actual Study Completion Date : | October 30, 2020 |

Arm | Intervention/treatment |
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Endoscopic Vein Harvest (EVH)
An endoscopic vein harvest allows a portion of vein from the inside of the leg to be removed through small incisions. This reduces the length of the incision by several inches. An endoscope, or video camera, is used to view the vein and remove the needed length.
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Procedure: Vein Harvesting Procedures
Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. |
Open Vein Harvest (OVH)
Open vein harvesting is the traditional method for vein harvesting. It is performed under direct vision using a single long incision or, more commonly, multiple-smaller incisions (referred to as "bridging" technique) along the course of the vein.
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Procedure: Vein Harvesting Procedures
Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as "bridging" technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH. |
- Investigate the impact of SVG harvesting techniques - OVH vs. EVH on MACE, a composite end point of all-cause mortality, nonfatal myocardial infarction and repeat revascularization, over the active follow-up period of the study postoperatively. [ Time Frame: 4.5 Years ]The primary efficacy end point is the composite rate of death from any cause, myocardial infarction or repeat revascularization (Major Adverse Cardiac Events - MACE) throughout the multi-year Study period. Each randomized subject (either in the Endoscopic or in the Open vein harvesting group) will be followed after the index CABG to capture the time-to-MACE event, where an 'EVENT' will be defined as either death (all cause) or a myocardial infarction or a revascularization procedure during the follow-up period.
- Investigate the impact of SVG harvesting techniques - OVH vs. EVH on MACE, a composite endpoint of all-cause mortality, nonfatal myocardial infarction and repeat revascularization, at one and three-year postoperatively. [ Time Frame: 6.5 years ]The secondary efficacy end point is the MACE rate at one and three-years post-CABG. The investigators believe that the proposed CSP# 588 REGROUP Trial will be uniquely positioned to fill a significant gap in existing knowledge regarding the long term MACE rates of EVH in CABG and improve the quality of the care we provide to our Veterans and more broadly to all patients undergoing coronary revascularization. In addition, the investigators believe that CSP# 588 findings will significantly impact the VA and national cardiac surgery coronary revascularization guidelines.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

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): NCT01850082
United States, Arizona | |
Southern Arizona VA Health Care System, Tucson, AZ | |
Tucson, Arizona, United States, 85723 | |
United States, California | |
San Francisco VA Medical Center, San Francisco, CA | |
San Francisco, California, United States, 94121 | |
United States, Florida | |
North Florida/South Georgia Veterans Health System, Gainesville, FL | |
Gainesville, Florida, United States, 32608 | |
Miami VA Healthcare System, Miami, FL | |
Miami, Florida, United States, 33125 | |
James A. Haley Veterans' Hospital, Tampa, FL | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | |
Boston, Massachusetts, United States, 02130 | |
United States, Minnesota | |
Minneapolis VA Health Care System, Minneapolis, MN | |
Minneapolis, Minnesota, United States, 55417 | |
United States, New Mexico | |
New Mexico VA Health Care System, Albuquerque, NM | |
Albuquerque, New Mexico, United States, 87108-5153 | |
United States, New York | |
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | |
New York, New York, United States, 10010 | |
United States, North Carolina | |
Asheville VA Medical Center, Asheville, NC | |
Asheville, North Carolina, United States, 28805 | |
Durham VA Medical Center, Durham, NC | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Louis Stokes VA Medical Center, Cleveland, OH | |
Cleveland, Ohio, United States, 44106 | |
United States, Oregon | |
VA Portland Health Care System, Portland, OR | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | |
Pittsburgh, Pennsylvania, United States, 15240 | |
United States, Texas | |
Michael E. DeBakey VA Medical Center, Houston, TX | |
Houston, Texas, United States, 77030 | |
United States, Wisconsin | |
Clement J. Zablocki VA Medical Center, Milwaukee, WI | |
Milwaukee, Wisconsin, United States, 53295-1000 |
Study Chair: | Marco A Zenati, MD MSc | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01850082 |
Other Study ID Numbers: |
588 |
First Posted: | May 9, 2013 Key Record Dates |
Last Update Posted: | December 3, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Coronary artery disease CABG Coronary revascularization |
Endoscopic vein harvest Saphenous vein graft Graft failure |