Randomized Endo-Vein Graft Prospective (REGROUP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01850082
First received: April 18, 2013
Last updated: July 23, 2014
Last verified: July 2014

April 18, 2013
July 23, 2014
September 2013
September 2019   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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 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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01850082 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
The secondary efficacy end point is the MACE rate at one and three-years post-CABG. We 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, we believe that CSP# 588 findings will significantly impact the VA and national cardiac surgery coronary revascularization guidelines.
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 ] [ Designated as safety issue: No ]
The secondary efficacy end point is the MACE rate at one and three-years post-CABG. We 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, we believe that CSP# 588 findings will significantly impact the VA and national cardiac surgery coronary revascularization guidelines.
Not Provided
Not Provided
 
Randomized Endo-Vein Graft Prospective
CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Bypass Grafting
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.
  • 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.
    Intervention: Procedure: Vein Harvesting Procedures
  • 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.
    Intervention: Procedure: Vein Harvesting Procedures
Zenati MA, Gaziano JM, Collins JF, Biswas K, Gabany JM, Quin JA, Bitondo JM, Bakaeen FG, Kelly RF, Shroyer AL, Bhatt DL. Choice of vein-harvest technique for coronary artery bypass grafting: rationale and design of the REGROUP trial. Clin Cardiol. 2014 Jun;37(6):325-30. doi: 10.1002/clc.22267. Epub 2014 Mar 14. PubMed PMID: 24633760. .

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1150
October 2019
September 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Marco A Zenati, MD MSc (857) 203-6815 marco_zenati@hms.harvard.edu
United States
 
NCT01850082
588
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Study Chair: Marco A Zenati, MD MSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Department of Veterans Affairs
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP