CSP #588 - Randomized Endo-Vein Graft Prospective (REGROUP) Trial
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Sponsor: VA Office of Research and Development

CSP# 588 – VERSION CONTROL LOG 
Changes from Version 1, June 1, 2013 to Version 1.1, August 1, 2013 
Page 
Section 
Description of Change   
All 
All 
Version number changed to 1.1 and issue date changed to August 1, 
2013. 
17 
Schedule of Events 
Form 00 from Contact Information changed to Screening Log. 
17 
Schedule of Events 
Divided Form 06 into two separate forms – Form 06 Post Operative 
Assessments and Form 07 Discharge Assessments. 
17 
Schedule of Events 
Renumbered the remaining forms. 
19 
Interim Follow-up 
Removed the word “either” from the last sentence. 
33 
Sample Size 
Calculation 
Changed the percent’s were changed with regards to the proportion 
of subjects who will not experience MACE between the two 
treatment arms – 16.5% in the EVH arm was changed to 83.5% and 
8.5% in the OVH arm was changed to 91.5%. 
Changes from Version 1.1, August 1, 2013 to Version 1.2, October 1, 2013 
All 
All 
Version number changed to 1.2 and issue date changed to October 1, 
2013 
 
Table of Contents 
Removed CV’s from Appendix C and replaced with “Definition of MI” 
V 
Executive 
Committee 
Members 
Changed email address for Deepak Bhatt to 
DLBHATTMD@post.harvard.edu 
 
9 
Study Flow 
Diagram 
Removed CIRB and replaced with IRB 
15 
Subject 
Assessments 
Under “Initial Assessment of Coronary Arteries”, added “In addition, 
the surgeon will be asked to describe a surgical plan indicating which 
bypass grafts are planned after reviewing the cardiac catheterization 
results” 
16 
Subject 
Assessments 
Under “Post-operative and Diagnostic Test Evaluation”, changed the 
collection of troponin levels to cardiac biomarkers – troponin levels 
or CPK levels are now both acceptable for the verification of an MI. 
CSP#588 – REGROUP 
Protocol Revision Log, Updated October 15, 2013 
1 
 

17 
Schedule of 
Assessments 
Changed timing of Form 14 “Termination” from Visit 49 to As 
Needed. 
 
Changed Form 19 to “Confirmation of Myocardial Infarction by Local 
Site”.   
 
Created form now called Form 20 “Confirmation of Myocardial 
Infarction by Clinical Events Committee”.   
 
Renumbered Form 20 “Cause of Death” to Form 21. 
19 
Monitoring Serious 
Adverse Events 
Under section d, removed SharePoint and replaced with DataFax 
system. 
20 
Subject 
Management 
Made clarification regarding the post-op ECG results by adding the 
following:   Per standard clinical care and most recent guidelines 
[Thyegesen 2012], cardiac biomarkers (preferably cardiac Troponin I 
or T) will be obtained if the 12-lead EKG demonstrates evidence of 
type 5 [Thyegesen 2012] myocardial infarction, including new 
pathologic Q waves or new Left Bundle Branch Block.  The cardiac 
biomarker will be obtained every eight hours until a downward trend 
is seen in the level. 
A-5 
Informed Consent 
Modified the collection of troponin levels (48 hours post-op) to be 
performed only if clinically indicated as follows:: 
“On the first and second day after your surgery, you will have an 
electrocardiogram - also known as an EKG.  This test is routinely 
performed on CABG patients but the results will also be used for 
research purposes.  If the EKG indicates there is new damage to your 
heart, known as a myocardial infarction (MI), then approximately two 
tablespoons of your blood will be drawn to check cardiac biomarkers. 
This is because cardiac biomarker levels will become increased in the 
blood when there is new heart damage. This test will be repeated 
every eight hours only if the level is increasing.  Once it is determined 
the level is decreasing or remains in a normal range no further levels 
will be drawn.  This blood test will help determine if you have had any 
new damage to your heart.   Cardiac biomarker tests are  frequently 
performed on CABG patients but the results will also be used for 
research purposes.” 
A-8 
Informed Consent 
Modified section under “Information about you is protected in the 
following way” to read as follows: 
Your research records will be kept indefinitely or until the law allows 
CSP#588 – REGROUP 
Protocol Revision Log, Updated October 15, 2013 
2 
 

 
their destruction in accordance with the VA Record Control Schedule 
(www1.va.gov/VHAPUBLICATIONS/RCS10/rcs10-1.pdf).  Records will 
be destroyed, when allowed, in the following manner. 
Paper records will be shredded.  Electronic records will be destroyed 
in a manner in which they cannot be retrieved.  The data from this 
study will be entered into a VA CSP Data Repository managed by the 
VA CSP Data Coordinating Center in Perry Point, MD and used for 
future IRB approved research.     
C-1 
Definition of MI 
New Appendix C to include the guidance for the definition of Type 5 
Myocardial Infarction (MI related to CABG).  Previous Appendix C, 
“Curricula Vitae” has been removed. 
D-1 
BRDP 
Removed Craig Kreisler as statistical programmer and added Mike 
Beam as Computer Assistant 
D-4 
BRDP 
Updated “Schedule of Assessments” table to reflect changes made to 
the protocol. 
F-1 
Vein Harvester 
Qualifications 
Changed/modified former Appendix F: “ Participation/Harvester 
Qualifications” and replaced with :  “Site Selection Process:  Vein 
Harvester Qualification Policy” 
CSP#588 – REGROUP 
Protocol Revision Log, Updated October 15, 2013 
3 
 

FORM REVISION RECORD 
FOR 
CSP# 588 REGROUP STUDY 
 
Changes from Version 1, Dated June 1, 2013 to Version 1.1 dated August 1, 2013  
FORM Page DESCRIPTION OF CHANGE 
1 
ALL 
Change to footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1 
Reworded instruction on Question 9 (“unless special approval obtained for 
enrollment” now reads “without special approval …”  
 
1 
Removed “<” and added “less than” on Question 11.  
 
2 
Changed instruction on Question 15 to:  “mark an x in the one box that best describes 
the reason” 
 
2 
Added an additional option to Question 15:  “subject refused to sign informed 
consent”  
 
3 
Changed instruction on Question 17 to:  “mark an x in the one box that best describes 
the reason” 
2 
ALL 
Change to footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1 
At top of form, changed “enrolled subjects” to “randomized subjects” 
 
4 
Add Peak Troponin T to Question 26. 
 
4 
Added to question 32:  “If experiencing angina classify by CCSS:  Class I, Class II, Class 
III, Class IV” 
 
7 
Changed “Serum Potassium” (Question 61) to “Potassium” with option to check 
either “Serum” or “Plasma” 
 
7 
Changed “GFR Calculated” (Question 64) to “eGFR (IDMS) < 60 
 
7 
Added extra boxes to Question 66 
 
9 
Added instruction to Question 80:  “If none, skip questions 81-83, calculate total 
score and sign form” 
 
10 
Removed “None” as an option for Questions 81 and 82. 
3 
ALL 
Added “Visit No” to header and changed footer:  Version # and date changed to 
“Version 1.1, August 1, 2013” 
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ALL 
Added “Visit No” to header and changed footer:  Version # and date changed to 
“Version 1.1, August 1, 2013” 
CSP# 588  
Forms Revision Log 
 
                     1                        

5 
ALL 
Change to footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
2 
Added details to Question 14 (Vein mapping).  If yes, performed by, when performed, 
if preoperative, when. 
 
2 
Added Questions 20 and 21:  FiO2 and PO2 
 
3 
Added Questions 27 and 28:  FiO2 (mid-procedure) and PO2 (mid-procedure) 
 
4 
Added Questions 38, 39, 40, and 41:  PaCO2 (mid-procedure), ETCO2 (mid-
procedure), FiO2 (mid-procedure), PO2 (mid-procedure). 
 
4 
Added Questions 48 and 49:  FiO2 and PO2 
 
5 
Added Question 52:  Vein harvester 
 
2 - 8 
Renumber questions starting at question 20 
6 
ALL 
Changed title from Postoperative and Discharge Assessment” to Postoperative 
Assessments” 
 
ALL 
Change to footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1,2 
Moved question 2 and 13 “Troponin I” to question 21 “Peak Troponin I” 
 
1 
Question 2 (changed from question 3) was “ECG evidence of ischemia” and now is 
“ECG evidence of new pathologic Q waves or new LBBB” 
 
2 
Question12 (changed from question 14) was “ECG evidence of ischemia” and now is 
“ECG evidence of new pathologic Q waves or new LBBB” 
 
3 
Questions 23 thru 31 (discharge assessments) were moved to a new form:  Form 07 – 
Discharge Assessment 
 
1,2 
Renumbered questions 
7  
ALL 
New form:  Discharge Assessment 
Questions 23 thru 28 and questions 30 and 31 from Form 06 were moved to Form 07.  
Question 29 from form 6 “Coumadin” has been removed. 
8 
ALL 
Previously form 07 remains unchanged except for new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
9 
ALL 
Previously form 08 remains unchanged except for new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
10 
ALL 
Previously form 09 changed to reflect new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1 
Removed Visit # on form and replaced with “Date of Discharge Assessment” for 
Questions 1 thru 4 and “Date of Follow-up Assessment” for Questions 5 thru 11. 
11 
ALL 
Previously form 10 remains unchanged except for new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
CSP# 588  
Forms Revision Log 
 
                     2                        

12 
ALL 
Previously form 11 remains unchanged except for new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013”.  Visit # 
was added to header. 
13 
ALL 
Previously form 12 remains unchanged except for new form number and 
Changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
14 
ALL 
Previously form 13 remains unchanged except for new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013”.  Visit # 
was added to header. 
15 
ALL 
Previously form 14 changed to reflect new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1 
Question 5 added:  “Brief description of the serious adverse event” 
 
1,2 
Renumbered questions 6 thru 9.  Added Question 10 “Is a Follow-up Serious Adverse 
Event Form required?” 
16 
ALL 
Previously form 15 changed to reflect new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1 
Question 5 – changed “Recovering/Resolving” to “Ongoing – Recovering/Resolving”, 
and changed “not Recovered/Not Resolved” to “Ongoing – Not Recovered/Not 
Resolved” 
 
1 
Added Question 6 “Is another follow-up form expected for this SAE?” 
17 
ALL 
Previously form 16 remains unchanged except for new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013”.   
18 
ALL 
Previously form 17 changed to reflect new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1 
Moved question 2 “Event Number” into header of the form. 
 
1 
Removed question 8. 
19 
ALL 
Previously form 18 changed to reflect new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013” 
 
1 
Added MI # to the header information. 
20 
ALL 
Previously form 19 remains unchanged except for new form number and 
changed footer:  Version # and date changed to “Version 1.1, August 1, 2013”.   
Changes from Version 1.1, Dated August 1, 2013 to Version 1.2 dated October 1, 2013 
1 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
Question 5 modified to include the “availability of a participating surgeon available for 
the procedure” 
2 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
Question 3:  Race – added category of “Hispanic” 
CSP# 588  
Forms Revision Log 
 
                     3                        

 
4 
Question 26:  Changed Peak Troponin to:  “Peak Cardiac Biomarkers” this includes 
Troponin I OR Troponin T OR, CPKs 
 
7 
Question 51, “Stensos %”:  Added box to value 
 
7 
Added Question 54, “Intent to bypass” and Question 54a “If yes, Type of conduit to be 
used” 
 
7-11 
Renumbered questions 54 thru 85 
 
8 
Question 66 “C-Reactive Protein” added box to value 
3 
ALL 
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3 
Question 23:  Added “If no, provide reason:  ACT already therapeutic, 
Thrombocytopenia, Pre-op Plavix use, other specify”. 
 
4 
Question 35:  Added instruction “add total length of incisions – not the bridging” 
 
8 
Added new question 59:  “Bypass graft completed as indicated on Form 2, Q54” 
 
8,9 
Renumbered questions 60 thru 68. 
6 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
Question 2:  Added 2A, B, C:  Cardiac Biomarkers 
 
3 
Question 12:  Added 2A, B, C:  Cardiac Biomarkers 
 
4 
Removed Question 21:  “Peak Troponin I” 
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ALL 
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2 
Question 9:  Added instruction “If yes, complete Form 15 – SAE” 
11 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
Question 2:  Changed instruction from “If yes, complete form 15” to “If yes, complete 
form 15 and 19” 
12 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
Question 4:  Changed instruction from “If yes, complete form 15” to “If yes, complete 
form 15 and 19” 
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CSP# 588  
Forms Revision Log 
 
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19 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
Removed Question 3:  Gender 
 
1 
Changed Troponin levels to “Cardiac  Biomarkers” 
 
2 
Removed question 5 and created new form to capture this question (Form 20) 
20 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
New Form “Classification of Myocardial Infarction”.  Questions from Form 19 have been 
removed from that form and are now recorded on the new Form 20. 
21 
ALL 
Change to footer:  Version # and date changed to “Version 1.2, October 1, 2013” 
 
1 
Changed Form # from 20 to 21 
 
CSP# 588  
Forms Revision Log 
 
                     5                        

 
 
 
 
 
 
 
 
 
VA Cooperative Studies Program Protocol #588 
 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE -  
REGROUP TRIAL 
 
 
 
 
 
 
October 1, 2013 
 
Version 1.2 
 
 
 
Study Chairperson:  Marco A. Zenati, MD, MSc, FETCS, VAMC Boston, MA  
 
 
 
 
 
 
 
 
- P R I V I L E G E D   A N D   C O N F I D E N T I A L - 
Not to be Disseminated Beyond Official 
Committee Function and Use 
 
 

 
TABLE OF CONTENTS 
 
Page 
 
Glossary .......................................................................................................................................................... i 
 
Executive Summary ...................................................................................................................................... iii 
 
Executive Committee .................................................................................................................................... v 
 
I. 
Introduction and Background .......................................................................................................... 1 
 
II. 
Preliminary Research ....................................................................................................................... 5 
 
III. 
Study Objectives............................................................................................................................... 7 
A. 
Primary Endpoint ................................................................................................................ 7 
B. 
Primary Hypothesis ............................................................................................................. 7 
C. 
Secondary Objective  .......................................................................................................... 7 
D. 
Secondary Hypothesis ......................................................................................................... 7 
 
IV. 
Importance to the VA ....................................................................................................................... 7 
 
V. 
Summary of the Study Design .......................................................................................................... 8 
 
Figure 1.  Study Flow Diagram ......................................................................................................... 9 
 
VI. 
Subject Population ......................................................................................................................... 10 
A. 
Inclusion Criteria ............................................................................................................... 10 
B. 
Exclusion Criteria ............................................................................................................... 10 
C. 
Recruitment and Screening ............................................................................................... 10 
 
VII. 
Saphenous Vein Harvesting Techniques ........................................................................................ 11 
A. 
Technique of Open Vein Harvesting ................................................................................. 11 
B. 
Technique of Endoscopic Vein Harvesting ........................................................................ 12 
 
VIII. 
Human Rights and Informed Consent ............................................................................................ 13 
 
IX. 
Evaluation Procedures ................................................................................................................... 14 
A. 
Screening  .......................................................................................................................... 14 
B. 
Randomization .................................................................................................................. 15 
C. 
Subject Assessments ......................................................................................................... 15 
 
               Table 2.  Schedule of Events ............................................................................................. 17 
 
X. 
Post-Discharge Follow-up Assessments ......................................................................................... 18 
A. 
Six Week Visit  .................................................................................................................... 18 
B.           Interim Follow-Up  ............................................................................................................. 18 
C. 
Monitoring Serious Adverse Events .................................................................................. 18 
D. 
Missed Visits  ..................................................................................................................... 19 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
E. 
Termination ....................................................................................................................... 19 
 
XI. 
Quality Control Procedures ............................................................................................................ 20 
A. 
Standardization/Validation of Measurements ................................................................. 20 
B. 
Subject Management ........................................................................................................ 20 
C. 
Protocol Noncompliance ................................................................................................... 21 
D. 
Site Performance Monitoring ........................................................................................... 21 
 
XII. 
Data Management and Case Report Forms ................................................................................... 22 
A. 
Assessments, CRFs and their Frequency of Administration and Collection ..................... 22 
B. 
Data Collection and Data Entry ......................................................................................... 22 
C. 
Study Documentation and Records Retention ................................................................. 23 
D. 
Data Security Plan ............................................................................................................. 23 
E. 
Data Sharing Plan .............................................................................................................. 24 
 
XIII. 
Feasibility of the study within the VA System ................................................................................ 25 
 
XIV. 
Requirements for Participating Centers ........................................................................................ 25 
 
XV. 
Study Organization, Administration and Monitoring..................................................................... 27 
A. 
Monitoring Bodies............................................................................................................. 27 
B. 
Monitoring Subject Safety ................................................................................................ 28 
C. 
Monitoring Subject Intake and Probation/Termination of Participating Sites ................. 28 
D. 
Alternate Plan if Recruitment Goals are not Met ............................................................. 29 
E. 
Monitoring Medical Center Performance ......................................................................... 29 
F. 
Monitoring of Safety, Efficacy and Futility ........................................................................ 30 
 
XVI. 
Good Clinical Practices ................................................................................................................... 30 
A. 
Role of GCP ....................................................................................................................... 30 
B. 
Summary of Monitoring and Auditing Plans ..................................................................... 30 
 
XVII. 
Biostatistical Considerations .......................................................................................................... 31 
A. 
Expected Treatment Effects .............................................................................................. 31 
B. 
Sample Size Calculation for the REGROUP Study .............................................................. 31 
C. 
Duration of Study and Number of Participating Sites ....................................................... 32 
D. 
Statistical Analysis Plan ..................................................................................................... 32 
E. 
Interim Monitoring ........................................................................................................... 34 
F. 
Criteria for Study Termination .......................................................................................... 34 
G. 
Handling of Missing Data .................................................................................................. 35 
H. 
Reporting of Any Deviations from the Original Statistical Plan ........................................ 35 
 
XVIII. 
Publications .................................................................................................................................... 35 
A. 
Publication Policy .............................................................................................................. 35 
B. 
Planned Publications  ........................................................................................................ 36 
 
XIX. 
References ..................................................................................................................................... 36 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Appendices 
 
A. 
Informed Consent Document ......................................................................................... A-1 
 
B. 
Budget .............................................................................................................................. B-1 
 
C. 
Denfition of MI ................................................................................................................. C-1 
 
D. 
Biostatistical and Research Data Processing  .................................................................. D-1 
 
E. 
Research Data Forms ....................................................................................................... E-1 
 
F. 
Site Selection Process:  Vein Harvester Qualifications .................................................... F-1 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
GLOSSARY 
ABI 
Ankle-Brachial Index 
BIRLS 
Beneficiary Identification Records Locator Subsystem 
BMI 
Body Mass Index 
CABG 
Coronary Artery Bypass Grafting 
CEC 
Clinical Events Committee 
CI 
Confidence Interval 
CPRS 
Computerized Patient Record System 
CRF 
Case Report Form 
CRNP 
Certified Registered Nurse Practitioner 
CSPCC 
Cooperative Studies Program Coordinating Center 
CSPCRPCC 
Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 
CSSEC 
Cooperative Studies Scientific Evaluation Committee 
DBMS 
Database Management System 
DCF 
Data Clarification Form 
DMC 
Data Monitoring Committee 
EACTS 
European Association for Cardiothoracic Surgery 
EC 
Executive Committee 
ESC 
European Society of Cardiology 
EVH 
Endoscopic Vein Harvest 
GCP 
Good Clinical Practices 
HDL 
High Density Lipoproteins 
HIPAA 
Health Insurance Portability and Accountability Act 
HRC 
Human Rights Committee 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
ISMICS 
International Society for Minimally Invasive Cardiothoracic Surgery 
ITA 
Internal Thoracic Artery 
ITT 
Intent-to-Treat 
LAD 
Left Anterior Decending 
LAO 
Left Anterior Oblique 
LDL 
Low Density Lipoproteins 
LOI 
Letter of Intent 
MACE 
Major Adverse Cardiac Events 
MAR 
Missing at Random 
MDWS 
Medical Domain Web Services 
MI 
Myocardial Infarction 
OCT 
Optical Coherence Tomography 
OMT 
Optimal Medical Therapies 
OR 
Operating Room / Odds Ratio 
OVH 
Open Vein Harvest 
PA 
Physician Assistant 
PCI 
Percutaneous Coronary Intervention 
QA 
Quality Assurance 
QOL 
Quality of Life 
RAO 
Right Anterior Oblique 
RCT 
Randomized Control/Clinical Trial 
REGROUP 
Randomized Endo-Vein Graft Prospective (CSP#588) 
ROOBY 
Randomized On/Off Bypass (CSP#517) 
SAE 
Serious Adverse Event 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
i 
 

 
SAP 
Statistical Analysis Plan 
SAQ 
Seattle Angina Questionnaire 
SCIP 
Surgical Care Improvement Project 
SI 
Site Investigator 
SMART 
Site Monitoring, Auditing and Review Team 
SQL 
Structured Query Language 
SQWM 
Surgical Quality Workflow Manager 
STS 
Society of Thoracic Surgeons 
SVG 
Saphenous Vein Graft 
VA 
Veterans Administration 
VAMC 
Veterans Affairs Medical Center 
VASQIP 
VA Surgery Quality Improvement Program 
VCSS 
Venous Clinical Severity Score 
VINCI 
Veteran Informatics and Computing Infrastructure 
VSSC 
VHA Support Service Center 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
ii 
 

 
EXECUTIVE SUMMARY 
 
Background: 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 Clinical Trial (RCT) with long-term follow-up.  
 
Objectives: 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. The primary hypothesis 
is that a significantly smaller proportion of CABG subjects with vein grafts harvested by the open technique will 
experience a MACE event compared to CABG subjects with vein grafts harvested by the endoscopic technique 
during the follow-up period. 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. 
 
Design: 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. Assessments will be collected at multiple time points 
including: baseline, intraoperatively, postoperatively, at discharge or 30 days after surgery if still hospitalized. 
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 intervals 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 using VA clinical and administrative 
databases (CPRS, VASQIP, etc) will be performed centrally by the Study Chair’s office for another two years. 
 
 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
iii 
 

 
Sample Size and Study Duration: This study will enroll approximately 1150 subjects requiring CABG at 16 VA 
Medical Centers with expertise in both techniques of vein harvesting. Assuming an enrollment rate of two 
subjects/medical center/month, total enrollment will take approximately three years to complete.  With at least 
one-year follow-up period for the last subject randomized and two additional years of passive follow-up by the 
chair’s office, the total duration of the study will be approximately six and half years.   
 
Subject Population: Any subject requiring a non-emergent CABG will be considered for entry into the study. 
Subjects who are hemodynamically unstable, have moderate to severe valvular disease or are unwilling or 
unable to provide informed consent will be excluded. 
 
Treatments: 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. 
 
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Executive Committee Members 
 
 
Marco A. Zenati, MD MSc FETCS 
Professor of Surgery 
Harvard Medical School 
Chief of Cardiac Surgery, VABHCS  
Boston, MA  
Office:  857 203-6202  
Email:  Marco_Zenati@hms.harvard.edu 
 
Jerene M. Bitondo, PA-C 
Chief Physician Assistant 
Massachusetts General Hospital 
Cox 630 55 Fruit Street 
Boston, MA  02114 
Office:  617-724-4825 
Email:  jbitondo@partners.org 
 
Rosemary F. Kelly, MD 
Division of Cardiothoracic Surgery 
University of Minnesota, MMC 207 
420 Delaware Street, SE 
Minneapolis, MN  55455 
Office:  612-725-2148 
Email:  kelly071@umn.edu 
 
Faisal G. Bakaeen, MD, FACS 
Baylor College of Medicine, 
One Baylor Plaza 
Houston, TX 77030 
Office: 713 794-7892 
Email: fbakaeen@bcm.edu 
 
Deepak L. Bhatt, MD MPH 
Professor of Medicine, Harvard Medical School 
Chief of Cardiology, VA Boston Healthcare System 
1400 VFW Parkway, 5B113 
West Roxbury, MA  02132 
Office:  857-203-6840 
Fax:  857-203-5550 
Email:  DLBHATTMD@post.harvard.edu  
 
J. Michael Gaziano, MD, MPH 
MAVERIC (151 MAV) 
VA Boston Healthcare System 
150 South Huntington Avenue 
Jamaica Plain, MA  02130 
Office:  617-278-0848 (Brigham and Woman’s 
Hospital) 857-364-9500, x4201 (VA) 
Email:  Michael.Gaziano@va.gov 
 
Jennifer M. Gabany, CRNP, MSN, CCRC 
National Nurse Coordinator, CSP 588 REGROUP 
Division of Cardiothoracic Surgery 
VA Boston, MA 
Email:  Jennifer.Gabany@va.gov  
 
Kousick Biswas, PhD 
VA Maryland Healthcare System 
CSPCC 151E 
Building 362T 
Boiler House Road 
Perry Point, MD  21902 
Office:  410-642-2411, x5283 
Email:  Kousick.Biswas@va.gov 
 
Cindy L. Colling, R.Ph., MS 
CSPCRPCC (151-I) 
2401 Centre Avenue SE 
Albuquerque, NM  87106-4180 
Office:  505-248-3200 
Email:  Cynthia.colling@va.gov 
 
 
 
 
 
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I.  
INTRODUCTION AND BACKGROUND  
 
In recent years, a consensus has emerged in the literature and in the Cardiac Surgical 
community that a definitive, adequately powered, prospective randomized controlled trial (RCT) is 
necessary to definitively assess the long-term clinical outcomes of CABG patients whose veins were 
harvested endoscopically. The need for a RCT was discussed first by the Duke Clinical Research Institute 
group in their seminal 2009 study published in the New England Journal of Medicine (Lopes 2009). Based 
on the results of a CSP #517 ROOBY sub-analysis, our group in Boston also recommended a RCT of EVH 
vs. OVH (Zenati 2011). Furthermore, an Editorial authored by the Committee that drafted the original 
2005 ISMICS guidelines recommending EVH, has now expressed significant concerns on the long-term 
patency and adverse effects of EVH and recommends a RCT (Cheng 2010). Professor Angelini’s group in 
Bristol, UK in an Editorial in Nature Medicine supports a large RCT on EVH vs. OVH (Patel 2009). 
Kempfert in an Expert Review of EVH discusses the need for a RCT with long-term outcomes to 
definitively assess EVH’s safety profile (Kempfert 2011); in addition, Mariani from The Netherlands also 
advocates a RCT (Mariani 2011). All three external reviewers of our original Letter of Intent for CSP# 588 
strongly supported our proposal for a RCT. We believe that a large multicenter prospective randomized 
trial taking into consideration important confounding factors will be indispensable before clearer 
guidelines can be formulated in favor or to the disadvantage of EVH.  
 
Coronary artery bypass grafting is the most common major surgical procedure in the U.S. 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 
internal thoracic artery (ITA) remains the conduit of first choice due to its superior long-term patency 
leading to superior clinical outcomes, which is the result of near-perfect integrity of its intima layer 
(Loop 1986). The left anterior descending (LAD) coronary artery is the most important coronary artery, 
supplying up to 70% of the left ventricle. Therefore, the left ITA-LAD bypass graft is currently the gold 
standard for surgical revascularization, with patency rates of 96% at one year, 90% at three years and 
86% at 10 years (Loop 1989). 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 ubiquitously in contemporary CABG with an average of two vein grafts per 
CABG procedure (Class IIa, Level B) (Brown 2010; Barner 2008).  
 
The traditional method of vein harvesting with an open longitudinal incision along the course of 
the greater saphenous vein has been associated with complications including dehiscence, cellulitis, 
lymphangitis, drainage, edema, pain, hematomas, skin necrosis, and infection (Bitondo 2002). These in 
turn lead to delayed wound healing, increased length of hospital stay, higher cost of postop care, and 
greater patient discomfort. Bitondo and colleagues showed that OVH is associated with a 25% risk of leg 
wound complications, creating an important clinical and economic burden (Bitondo 2002; Goldsborough 
1999). As an alternative, EVH was first introduced clinically in 1996 (Lumsden 1996) and has since been 
reported to reduce leg wound complications and improve patient satisfaction while decreasing resource 
utilization (Bonde 2005).  Encouraging short-term (≤ six months) clinical (less wound morbidity, less pain, 
better cosmetic results, and improved patient satisfaction) and graft patency outcomes have been 
described (Andreasen 2008; Kiaii 2002; Perrault 2004; Puskas 1999; Yun 2004, Markar 2010). In a recent 
“Best Evidence Topic” study (Tennyson 2010), a review of the literature showed EVH reduced the level 
 
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of postop pain (pain score for EVH=0.52±0.95; OVH=1.02±1.51; p=0.03) and wound complications (range 
from 3% to 7.4% for EVH and 13% to 19.4% for OVH). These clinical benefits were associated with high 
levels of patient satisfaction.  
 
Since its clinical introduction in 1996, EVH has increased in popularity to become the preferred 
method of SVG harvesting in the United States. According to the Society of Thoracic Surgeons’ National 
Database (www.sts.org), EVH was utilized in ~80% of CABG procedures performed in the United States 
in 2008. A recent Editorial published in The New England Journal of Medicine predicted the “demise of 
open vein harvesting” in the near future in favor of EVH (Aranki 2009). In the U.S., EVH is almost 
universally performed by mid-level practitioners (Physician Assistants or Nurse Practitioners), rather 
than attending surgeons, residents, or fellows, and generally takes longer to learn than OVH. No 
universally accepted metrics for proficiency are available and training is usually provided by vendors. 
Cadwallader and associates undertook a systematic review and meta-analysis of the use of EVH vs. OVH 
in the United Kingdom. They concluded that EVH has a role in vein harvesting but is clearly operator 
dependent. EVH is therefore only preferable to OVH when performed by an experienced practitioner 
(Cadwallader 2009). EVH requires video equipment and a video tower for the endoscope. Before 
initiating EVH, some centers administer an intravenous bolus of 5,000 international units (IU) of 
unfractionated heparin to prevent vein thrombosis: this practice is based on limited evidence from a 
small, single-center study that showed a decrease in fibrin clots in veins harvested with EVH when a 
bolus of intravenous heparin was administered prior to the initiation of EVH (Brown 2007).  
 
EVH can be performed with one of the commercially available systems that follow similar 
technical steps (VasoView®, available since 1996 and first marketed by Origin Med Systems, then by 
Boston Scientific/Guidant Cardiac Surgery, and currently by MAQUET Cardiovascular, Wayne, NJ 
www.maquet.com [estimated EVH U.S. market share 90%]; Virtuosaph™, introduced in 2005, Terumo 
Cardiovascular Systems Corporation, Ann Arbor, MI www.terumo-cvs.com/virtuosaph [approximate 
estimated EVH U.S. market share 8%]; all using CO2 insufflation for visualization and dissection. Briefly, a 
1.5 to 2.0 cm incision is made medially above or below the knee, depending on the length of the vein 
required. Harvesting is performed under video guidance with a rigid endoscope and is directed towards 
the groin region as far proximally as possible. If a longer segment of a vein is required, the endoscope 
may also be directed distally through the same incision. Side branches are divided by using bipolar 
cauterizing scissors or a bisector. EVH requires CO2 to insufflate the subcutaneous cavity in the lower 
extremity and frequent use of bipolar cautery in the vicinity of the saphenous vein in order to divide the 
side branches; neither insufflation nor bipolar energy is required for OVH. The use of cautery has been 
proposed to cause thermal injury to the vessel wall, which may impair the graft quality by compromising 
the viability of endothelial cells and resulting in platelet aggregation and thrombosis. Encouraging short-
term (≤six months) clinical and graft patency outcomes have been described (Andreasen 2008; Kiaii 
2002; Perrault 2004; Puskas 1999; Yun 2004).  
There is concern that relatively longer manipulation times and the use of rigid devices in EVH 
may cause direct mechanical injury to vein grafts.  Traditional surgical principles for handling vascular 
tissue emphasize a “no-touch” approach during dissection to minimize the risk of intimal endamage 
(Gundry 1980). EVH inherently requires forces to be applied to the vein that are usually avoided in open 
harvest, including traction, adventitial stripping and venous compression. There is a lack of unanimity on 
 
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the role of EVH on premature graft loss (Ouzunian 2010) which may be explained by variability of 
techniques and level of experience among centers. Desai and associates, in a prospective pilot study 
using Optical Coherence Tomography (OCT) imaging, noted that veins procured by novice harvesters 
had nearly 50% more discrete injuries than veins procured by experienced harvesters (Brown 2007). 
Rousou and colleagues recently reported that, compared to OVH, EVH adversely affects vein endothelial 
function (Rousou 2009). They used epifluorescence multiphoton microscopy (a technique that measures 
endothelial viability and functionality in real time with greater sensitivity than other methods) and 
demonstrated endothelial and smooth muscle cell damage in vein grafts with reduced endothelial cell 
viability, attenuated calcium mobilization, and nitric oxide production in the EVH group.  Endothelial 
dysfunction enhances thrombogenicity and may lead to early thrombosis and accelerated SVG failure. 
Compromised endothelial integrity is the primary determinant in the interrelated pathogenesis of 
thrombosis, intimal hyperplasia and atherosclerosis within the SVG (Thatte 2001). Considering all the 
basic science and clinical arguments, together with increased risk of adverse events that inevitably 
follows graft failure, the goal of harvesting SVG with as near-perfect integrity of its intima layer as 
possible seems prudent until available evidence demonstrates otherwise.  
Because the enthusiastic adoption of EVH preceded any professional consensus on this topic, in 
2005 an ad hoc Committee of the International Society for Minimally Invasive Cardiothoracic Surgery 
(ISMICS www.ISMICS.org) published a consensus statement on the use of EVH vs. OVH in CABG (Allen 
2005). Based on reports of short-term comparable rates of MACE, angiographic SVG patency, and 
quality of the harvested conduit with the two techniques in both randomized and non-randomized trials, 
the Members of the ISMICS Consensus Committee suggested that either EVH or OVH can be used to 
procure SVG conduits for CABG. In addition, the Consensus Committee also recommended that EVH be 
the “standard of care” (Class I, Level A) in order to reduce wound-related complications, improve patient 
satisfaction, and to decrease postop pain, length of hospital stay, and use of outpatient wound-
management resources.  EVH is listed in a respected reference textbook entitled: “Evidence Based 
Cardiology –Third Edition” edited by Yusuf as a Class IIa (Class of Recommendation IIa: conflicting 
evidence and/or divergence of opinion about the efficacy with weight of evidence in favor of efficacy) 
recommendation based on level B evidence (Brown 2010).  
Based on widespread concerns for excessive trauma to the SVG during EVH, in July of 2009, 
Lopes and associates from the Duke Clinical Research Institute (DCRI) reported in The New England 
Journal of Medicine on the long-term follow-up results of the Project of Ex-vivo Vein Graft Engineering 
via Transfection IV trial (PREVENT-IV) (Lopes 2009). The rate of vein-graft failure was significantly higher 
in those subjects who underwent EVH (46.7% vs. 38.0 %; odds ratio 1.45, 95% CI 1.20-1.76). EVH was 
also associated with a significantly higher combined rate of mortality, myocardial infarction, and repeat 
revascularization three years after surgery (20.2% vs. 17.4%; adjusted hazard ratio 1.22, 95% CI 1.01-
1.47). The Authors’ findings constituted the first published report of EVH resulting in poorer clinical 
outcomes than the OVH technique. For the first time, EVH was found to be independently associated 
with vein graft failure and adverse clinical outcomes. This paper also provided important long-term 
follow-up data that contradicted accepted clinical practice and called into question the wisdom of the 
ISMICS recommendations (Allen 2005). The DCRI Group recently reported an additional sub-analysis of 
the PREVENT-IV study  and reported no difference in angiographic or 5-year clinical outcomes in patients 
who underwent open versus closed tunnel endoscopic harvesting  (47.1% vs. 43.8% p=0.72; 24.5% vs. 
 
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26.8% p=0.26) (Van Diepen 2013). These findings suggest that the increased risk associated with EVH 
reported in the previous PREVENT-IV analysis does not seem to be associated with a specific endoscopic 
harvesting device. 
A meta-analysis of 102 studies (including Lopes’), published in 2010, compared EVH to OVH in 
CABG (Markar 2010). Results of this meta-analysis showed that long-term graft patency in SVG 
harvested by OVH was better than those harvested by EVH (pooled odds ratio = 1.25, p=0.0039).  
More recently, the Task Force on Myocardial Revascularization of the European Society of 
Cardiology (ESC) and the European Association for Cardiothoracic Surgery (EACTS) published their 
updated Guidelines on Myocardial Revascularization (Wjins 2010). According to this consensus 
statement, incorporating new evidence accumulated since 2009, “endoscopic vein graft harvesting 
cannot be recommended at present as it has been associated with vein graft failure and adverse clinical 
outcomes”. This statement contradicts the 2005 ISMICS guideline and accepted clinical practice. Given 
the potential implications of the long-term impact of SVG graft failure on CABG outcomes, the role of 
EVH is currently the subject of substantial controversy in the literature (Aranki 2009; Cheng 2010; 
Connolly 2009; Patel 2009; Tennyson 2010).  
It is well established that vein graft failure (i.e. severe graft stenosis or occlusion) adversely 
affects long-term clinical outcomes after CABG (Lopes 2012; Buxton 2009; Halabi 2005). In CSP #517 
ROOBY, ineffective revascularization (defined as presence of non-FitzGibbon “A” graft to one of the 
main coronary territory) was associated with worse composite clinical outcomes at one-year (Table 1) 
(Hattler 2012).  
Table 1.  ROOBY 1 Year Graft Patency Results 
FitzGibbon described clinical outcomes and vein graft failure rates among 1,388 patients who 
underwent a first CABG surgery from 1969-1994 (FitzGibbon 1996). This study showed that both 
mortality and vein graft failure rates increased over time, particularly seven years after CABG. At five 
years, survival rates were around 94% and vein graft failure rate was 25%. Halabi and associates found 
that early vein graft failure was associated with worse long-term outcomes of death, myocardial 
infarction and revascularization and that these results were driven by early revascularization (Halabi 
2005). In their study, vein graft failure was the strongest predictor of the composite clinical outcome at 
10 years. In the PREVENT-IV Trial, vein graft failure occurred in 787 of 1,829 patients (43%) [Alexander 
 
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2005].  Using the same PREVENT-IV Trial database, Lopes and associates studied data from 1,829 
patients who underwent CABG surgery and had an angiogram performed up to 18 months following 
surgery (Lopes 2012). They demonstrated that vein graft failure was associated with an increased risk 
for the composite of death, myocardial infarction or repeat revascularization with an adjusted HR of 
5.23. The composite outcome was driven by high rates of repeat revascularization in the patients with 
vein graft failure. It should be noted that in all of these studies, ITA-LAD was used in the vast majority of 
patients (>93%) according to the predominant practice and recommendations (Class I, Level C) (Brown 
2010).  
 
II. 
PRELIMINARY RESEARCH  
 
Results of the VA CSP #517 ROOBY trial were recently published (Shroyer 2009). We have 
previously published the results of two preplanned sub-analyses of the ROOBY trial (Zenati 2006; Zenati 
2007). More recently, we published the results of a pre-planned sub-analysis examining clinical and SVG 
patency outcomes in ROOBY trial patients who underwent either EVH or OVH (Zenati 2011). From 
February 2002 through April 2007, the ROOBY trial enrolled 2,203 patients. Beginning in April 2003, 
prospective collection of data regarding SVG harvesting technique was begun. A total of 1,471 patients 
(564 EVH, 907 OVH) had the harvesting technique recorded and had a SVG used as a bypass conduit. The 
30-day composite end point was known for all these patients. One-year composite follow-up was 
determined for 96% (555 EVH, 859 OVH) of these patients.  Follow-up angiography was obtained in 894 
subjects (341 EVH, 553 OVH). For both the population of patients with their SVG harvest approach 
recorded (n = 1,471) and the sub-set with one-year cardiac catheterization (n = 894), the pre-operative 
patient characteristics were generally balanced between the EVH and the OVH groups. Almost all 
patients were male (99%), a reflection of the VA cardiac surgical patient population. Sixty-eight percent 
of patients had three vessel coronary artery disease and approximately 83% of patients had preserved 
left ventricular function. Less than 15% of study patients required urgent surgery. The quality of the 
harvested SVG was assessed as “good” in 81.6% of EVH and 85.6% of OVH patients, “intermediate” in 
15.7% of EVH and 12.7% of OVH, and “poor” in 2.8% of EVH and 1.7% of OVH (p = NS). For the short-
term composite end point there was no significant difference between EVH vs. OVH. More OVH than 
EVH patients (1.3%) suffered renal failure (1.3% vs. 0.0%; p=0.01) and more OVH patients needed new 
mechanical support (1.7% vs. 0.4%; p=0.02).  There were no differences between EVH and OVH groups 
with respect to one-year composite outcome. For the subgroup of patients with one-year cardiac 
catheterization results, the rate of repeat revascularization was significantly higher in the EVH group 
than in the OVH group (6.7% vs. 3.4%, p<0.05), while the rates of non-fatal MI or death were similar. A 
mean of 2.02 SVGs were placed per patient, and a total of 1,807 SVGs were assessed for patency. The 
incidence of a patient having one or more occluded SVGs on follow-up angiography was 41.3% in the 
EVH group compared with 28.0% in the OVH group (p<0.0001). Overall SVG patency was 74.5% in the 
EVH group, significantly worse than the 85.2% rate in the OVH group (p<0.0001). Using multi-variable 
regression analysis, EVH was not identified as an independent and statistically significant predictor of 
the one-year composite outcome after holding other factors constant. Further, no interaction was 
identified between the SVG harvesting technique (EVH vs. OVH) and the use of an on-pump vs. off-pump 
approach (p = NS). Additionally, sensitivity analysis found no differential EVH vs. OVH impact for high 
volume vs. low volume EVH centers. 
 
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In conclusion, our sub-analysis of the CSP #517 dataset demonstrated that the one-year SVG 
occlusion rate was 25.5% in the EVH group and 14.8% in the OVH group (p<0.001). The MACE rate was 
8.2% in the EVH group vs. 4.8% in the OVH group (p=0.061), and the rate of repeat revascularization by 
PCI or redo-CABG was 6.7% in the EVH group vs. 3.4% in the OVH group (p<0.001). There was no 
interaction between EVH and on- or off-pump CABG by multivariate logistic regression analysis. Both the 
PREVENT-IV and ROOBY sub-analyses suffer from the same limitation: the basis for randomization was 
not the SVG harvest modality (EVH vs. OVH).  In addition, neither study accounted for other potentially 
important variables, such as device-related and experience-related EVH variables.  
 
Furthermore, we recently published a meta-analysis of long-term EVH vs. OVH graft patency 
including the results of our recent publication (Zenati 2012); in the five long-term observational studies 
from 1996 to 2011 included in our analysis,  SVG failure was expressed as the combination of 
angiographic occlusion and severe stenosis (FitzGibbon grades B+O). There were a total of 6,866 SVGs 
assessed by angiography in the five pooled studies. Both random and fixed effects models showed 
significantly lower graft patency with EVH. The random effect pooled OR was 1.62 (95% CI = 1.22 – 2.15; 
p = 0.0009) and the fixed effect pooled OR was 1.49 (95% CI = 1.33 – 1.68; p<0.0001) favoring OVH. We 
concluded that available evidence consistently identifies compromised SVG patency when the conduit 
was harvested with the EVH technique.  
 
 
Because of safety concerns regarding endoscopic vein-graft harvesting, the US Food and Drug 
Administration issued a request to analyze the Society of Thoracic Surgeons Adult Cardiac Surgery 
Database for endoscopic and open vein-graft harvesting–related outcomes. The resulting study was 
published in JAMA in 2012 (Williams 2012). In this study 235,394 Medicare patients undergoing isolated 
CABG surgery in 934 surgical centers between 2003 and 2008 were examined with a median 3-year 
follow-up. Fifty-two percent of patients received endoscopic vein-graft harvesting. In a propensity 
score–adjusted analysis that minimized the influence of confounding between groups, there were no 
significant differences between endoscopic vein-graft harvesting and open vein-graft harvesting in 3-
year mortality (13.2% vs 13.4%, respectively) or a composite of death, myocardial infarction, and 
revascularization (19.5% vs 19.7%, respectively). Compared with open vein-graft harvesting, endoscopic 
vein-graft harvesting was associated with a 13% lower harvest wound infection rate. Multiple 
sophisticated statistical techniques including sensitivity and subpopulation analyses confirm the 
robustness of the central findings. The study by Williams et al is important for several reasons. First is its 
sheer size and statistical power. Second, this investigation represents a snapshot picture of 
contemporary CABG surgery in the United States because it includes so many diverse sites with widely 
varying practice styles. The basic finding is that endoscopic vein-graft harvesting shows no difference in 
long-term mortality or need for revascularization.  
 
 
Taken together, the major subanalysis studies cited above (PREVENT-IV, ROOBY and STS) only 
establish uncertainty (or equipoise) over the safest and most effective vein harvesting technique for 
CABG over a long-term follow up and lay the foundations for our proposed randomized study. 
 
 
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III. 
Study Objectives 
 
A. 
Primary Endpoint: 
 To 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 . 
 
B. 
Primary Hypothesis: 
A significantly smaller proportion of CABG subjects with SVGs harvested by open 
technique will experience MACE post-surgery compared to CABG subjects with SVGs harvested 
by endoscopic technique during the active follow-up period. 
 
C. 
Secondary Objective: 
i. To 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 . 
ii. To 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, over the entire follow-up period (active and passive) of the study 
postoperatively. 
 
D.  
Secondary Hypothesis:  
i. One-year composite MACE rate will be 6 percentage points lower in the open 
harvesting group and three-year composite MACE rates will be at least 8-10 percentage points 
lower in the open vein harvesting group compared to the endoscopic vein harvesting group. 
ii. A significant smaller proportion of CABG subjects with SVGs harvested by open 
technique will experience MACE post-surgery compared to CABG subjects with SVGs harvested 
by endoscopic technique during the entire follow-up period 
 
Other objectives are: 
 
1. Investigate the impact of the two harvesting techniques - open vs. endoscopic - on clinical 
indicators of leg wound complications and subject satisfaction at six-weeks post-surgery; 
The hypothesis is the leg wound complications will be lower and satisfaction will be higher 
in the EVH group compared to OVH group.  
2. Compare subject quality of life scores according to the SVG harvest technique at six-week 
post-surgery; the hypothesis is the subjects’ quality of life scores will be higher in the EVH 
group compared to the OVH group. 
3. Determine the role of vein harvester experience on clinical outcomes  
 
 IV. 
Importance of the Study Topic to the VA and Its Patients 
 
CABG is the most common major surgical procedure in the U.S. and the VAMC Health System, 
and EVH is now the preferred modality of SVG harvesting in both the private sector and the VAMC (72% 
 
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EVH adoption rate in the VHA based on a 2009 survey commissioned by Dr. Gunner at VACO). Decisions 
regarding the choice of coronary revascularization (CABG vs. percutaneous coronary intervention [PCI]) 
rest primarily on the anticipated failure rate of CABG versus PCI. The recent ARTS II trial (Serruys 2010) 
showed comparable freedom from MACE in selected patients undergoing multi-vessel PCI versus CABG.  
 
In order to offer the safest and most durable revascularization strategy for veterans requiring 
CABG surgery, it is imperative to provide definitive evidence on the long-term clinical outcomes of EVH 
in order to minimize harvest site morbidity  (e.g. leg wound infection, hospital readmission, pain, 
mobilization, and appealing cosmetic results) while preserving long-term clinical outcomes. The quality 
of the harvested conduit is an important aspect to consider when comparing harvesting techniques. 
These features ultimately determine long-term patient morbidity and mortality rates following CABG 
surgery (Buxton 2009).  
 
V. 
Summary of the Study Design 
 
This study is a randomized, intent-to-treat, two-arm,  parallel design, multicenter study to 
compare clinical outcomes of major adverse cardiac events (MACE) of CABG subjects treated with SVG 
harvested with EVH and OVH during the trial period. Cardiac Surgery Programs at Veterans Affairs 
Medical Centers (VAMCs) with expertise in performing both EVH and OVH will be invited to participate 
in the study (EVH Program established for more than two years and at least 100 successful EVH cases 
performed by each mid-level provider or other designated individual involved with the study) (Desai 
2011). Subjects requiring elective or urgent CABG using cardiopulmonary bypass with use of at least one 
SVG will be screened using established inclusion/exclusion criteria. Subjects will be randomized to one 
of the two arms (EVH or OVH) after an experienced vein harvester is identified and assigned to the case. 
Assessments will be collected at multiple time points including: baseline, intraoperatively, 
postoperatively, at discharge or 30 days after surgery if still hospitalized. Assessment of leg wound 
complications will be completed at the time of discharge and at six-week post-surgery. Quality of life 
self- assessments will be completed at baseline, six weeks, and one year (by mail or telephone).  
Telephone follow-ups will occur at three-month intervals 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 using VA clinical and 
administrative databases (CPRS, VASQIP, etc.) will be performed centrally by the Study Chair’s office for 
another 2 years.  
 
The other secondary outcome measures are MACE at one and three-year post surgery, leg 
wound healing complications and Quality of Life. 
 
Two leading vendors (Maquet and Terumo) are currently marketing EVH device technologies for 
CABG.  Device-related and procedural information will be collected during the study.  
 
Subjects will receive concomitant optimal medical therapies (OMT) in both groups as 
recommended by the current 2011 American College of Cardiology/American Heart Association 
guidelines [Smith 2011). OMT will include formal smoking cessation counseling and the administration 
of aspirin, beta blockers, angiotensin converting enzyme inhibitors, and lipid-lowering medications.  
 
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Does not 
meet criteria 
Patient 
refusal 
Yes 
Yes 
Yes 
Yes 
FIGURE 1.  STUDY FLOW DIAGRAM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening assessment for inclusion/exclusion 
criteria with an IRB waiver for ICF 
Obtain Informed Consent 
Complete all baseline assessments 
Randomization 
OVH 
STOP -      
patient cannot 
be enrolled 
Complete Intra-Op and Post-Op Assessments  
6-week follow-up assessment - leg wound and 
patient satisfaction 
Patient requiring elective or urgent on-pump 
CABG procedure with use of at least one SVG 
Phone call follow-up assessment for events 
every three months until the decommissioning 
of the sites (QoL surveys at 1 year) 
Availability of experienced harvester 
Discharge Assessment (or 30-day) 
EVH 
Passive Follow-up for 
MACE 
 
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VI. 
Subject Population 
 
All subjects who are candidates for CABG and who will undergo surgery at a VAMC with 
demonstrated expertise for both OVH and EVH and qualify to participate in CSP-sponsored research will 
be invited to participate in the REGROUP study.  
 
A. Inclusion Criteria: 
• 
Age 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 and participating surgeon available for 
procedure 
  
B. 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 
 
C. Recruitment and Screening  
 
We propose a prospective, multicenter, two-arm, randomized clinical trial (RCT). A block 
randomization technique will ensure equal distribution of subjects, within each harvester, within each 
site, in both arms of the trial. The randomization schema will be generated using SAS (SAS, Cary, NC). 
 
Participating sites will be chosen based on availability of EVH/OVH harvesters (see Appendix F), 
but also based on CABG volume as well as ability and willingness of the local site surgeon investigator to 
meet enrollment goals. The local site surgeon investigators and research coordinators will be trained on 
study specific recruitment at the Investigator Meeting. Subsequently, each local site surgeon 
investigator will present the study protocol to the appropriate local clinical care providers for subjects 
undergoing CABG surgery at their site so those involved in the care of the subjects are familiar with the 
protocol requirements. Each site will have one full time dedicated research coordinator to facilitate 
enrollment.  Each site will obtain a waiver of informed consent/HIPAA for screening purposes from the 
local IRB and following this, will work with the clinical care team to identify subjects referred for CABG 
surgery who meet study criteria. Every CABG-only subject the site surgeon investigator deems as 
 
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meeting study criteria will be approached. After preliminary consultation and screening with a potential 
participant’s clinical team, the participating site’s research coordinator will approach each non-
emergent subject scheduled for a CABG-only procedure to discuss enrollment in the REGROUP study. 
After providing the potential subject adequate time to read the documents and to ask any questions, 
the research coordinator will obtain informed consent and collect all the baseline assessments. 
Randomization to either the EVH or OVH technique, stratified by harvester within site, will occur at the 
time of surgery after a qualified harvester is assigned to the case.  
 
We recognize the VA policy to include women and minorities in clinical research. Although we 
do not anticipate a large number of women or minorities to be recruited for this study due to the 
demographics of subjects receiving care at the VA, efforts will be made to recruit both women and 
minorities for the REGROUP trial. At present, there are no ongoing or submitted research studies that 
directly relate to the REGROUP trial.  
 
VII. 
Saphenous Vein Harvesting Techniques 
 
The greater saphenous vein lies in the subcutaneous fat on the medial aspect of the leg from the 
sapheno-femoral junction to the medial malleolus. Below the knee, the vein is accompanied by the 
saphenous nerve which should be preserved during harvest. The vein is usually larger proximally with a 
thicker, more fibrotic wall, while distally the vein is healthier but may be small. The vein wall is thicker 
than that of an arterial conduit and the media is nourished by the vasa vasorum so that smooth muscle 
necrosis is usual after harvesting and it is replaced by fibrous tissue that converts the vein into a rather 
rigid tube. This obviously restricts vasomotion after grafting. The endothelium of the vein is frequently 
damaged or lost even with meticulous harvesting  and preservation (Barner 1990) but regenerates over 
weeks (Busch 1986). Immediately prior to harvest, the lower extremities are circumferentially prepped 
with antiseptic solution (povidone-iodine or Hibiclens®) and the feet are placed in sterile stockinettes. 
Vein mapping is not used routinely and the selection of extremity is determined by presence of 
varicosities, any previous surgery, and the quality of skin and tissue.  
 
A. Technique of Open Vein Harvesting 
 
The conventional open harvesting technique requires an incision the length of the vein to be 
harvested or alternatively can be achieved by multiple small incisions (“bridging”). Dissection should be 
as atraumatic as possible, forceps should handle only the adventitia of the vein and stretch trauma 
minimized. Branches are controlled with clips or ligature. Cautery is rarely used during OVH to divide 
vein branches, but only to provide wound hemostasis before the incision is closed.  Following harvest, 
the vein is marked by placing a soft vascular bulldog clamp on the new distal end or by cannulating the 
new proximal end. The vein is gently distended with a physiologic solution at low pressure (no more 
than 150mmHg, ideally using specially designed pressure-limiting syringes). Closure of the incision is 
performed in layers with absorbable sutures followed by subcuticular closure. At the end of the 
operation, the leg wound is typically covered with a cotton gauze dressing and an elastic ace wrap is 
applied to the entire leg. The “bridging” OVH technique variant was shown to be associated with similar 
rates of leg wound complications versus open OVH (Carpino 2000) and requires more technical expertise 
and a longer training period. 
 
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The OVH technique is highly reproducible and can be performed by surgical trainees, including 
medical students, and mid-level providers like Physician Assistants (PA) or Certified Registered Nurse 
Practitioners (CRNP). OVH is associated with variable (2-18%) degrees of morbidity, such as wound 
infection, especially in high-risk patient subsets (obese, diabetics, females), non-infective wound healing 
disturbances, postoperative pain, and poor mobility. Such morbidity prolongs the length of hospital stay, 
increases health care costs, and reduces patient satisfaction (Carpino 2000; Markar 2010).  
 
B. Technique of Endoscopic Vein Harvesting  
 
The preparation for EVH is similar to OVH but there is an additional requirement for video 
equipment and a video tower for the endoscope. Before initiating EVH, some centers administer 5,000 
IU of intravenous heparin to prevent SVG thrombosis: this practice is based on limited evidence from a 
small, single center study that showed a decrease in fibrin clots in SVG harvested with EVH when low-
dose heparin was used (Brown 2007). EVH can be performed with one of the commercially available 
systems that follow similar technical steps (VasoView®, available since 1996 and first marketed by Origin 
Med Systems, then by Boston Scientific/Guidant Cardiac Surgery, and currently by MAQUET 
Cardiovascular, Wayne, NJ www.maquet.com [estimated EVH U.S. market share 90%]; Virtuosaph™, 
introduced in 2005, Terumo Cardiovascular Systems Corporation, Ann Arbor, MI www.terumo-
cvs.com/virtuosaph [approximate estimated EVH U.S. market share 8%]; all using CO2 insufflation for 
visualization and dissection (the system is “open” for the Terumo device). Briefly, a 1.5 to 2.0 cm incision 
is made medially above or below the knee, depending on the length of the vein required. Harvesting is 
performed under video guidance with a rigid endoscope and is directed towards the groin region as far 
proximally as possible. If three segments of vein are required, the endoscope may also be directed 
distally through the same incision. Side branches are divided by using bipolar cauterizing scissors or a 
bisector. EVH requires CO2 to insufflate the subcutaneous cavity in the lower extremity and frequent use 
of bipolar cautery in the vicinity of saphenous vein in order to divide the side branches; neither 
insufflation nor bipolar energy is required for OVH. The use of cautery has been proposed to cause 
thermal injury to the vessel wall, which may impair the graft quality by compromising the viability of 
endothelial cells and resulting in platelet aggregation and thrombosis (Rousou 2009). After the vein has 
been freed circumferentially from surrounding tissue and all branches have been divided, a small 
puncture is made under endoscopic guidance proximally over the SVG. The proximal end is clamped, 
divided, and then ligated.  After removing the vein from the leg, SVG is gently distended manually with a 
distending solution and the side branches are ligated with 4-0 silk ties. Any avulsed branches are either 
repaired by carefully approximating the adventitial layer with 7-0 Prolene sutures or excluded if 
fortuitously located between vein graft segments.  The incision is closed with absorbable subcutaneous 
and subcuticular sutures and then wrapped with an elastic ace bandage. The SVG is then placed in a 
storage solution (i.e. heparinized blood, physiological pH balanced salt solution or GALA solution) until it 
is ready for use. Incisions are closed after harvest with or without drains.  
 
Best practice EVH technique will be recommended at all sites and will include: 
Optimal preoperative preparation, including vein mapping whenever possible, plan the EVH procedure 
as having 3 separate stages: (a) choosing the incision site and making the incision, (b) dissecting the 
vessel and vessel tributaries, and (c) dividing the vessel branches. 
 
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Incision: decide on the best place to make the incision and mark the site, keep the length of the skin 
incision to a minimum, consider making the incision to correspond with tension lines of the skin. 
Heparin: an intravenous heparin bolus of a minimum of 1,000IU to a maximum of 5,000IU will be used at 
the beginning of the harvest. 
CO2 insufflation: use the lowest tunnel pressure possible to reduce the risk of CO2 embolism, monitor 
central venous pressure, use appropriate monitoring to be alerted to CO2 –related events.  The trocar 
cuff should be kept delated or minimally inflated to avoid interruption of blood flow inside the SVG. 
Dissection of the vessel: establish a regular sequence of dissection; use short, gentle motions, ensure 
that side branches are thoroughly dissected to allow adequate length during branch division, apply 
appropriate pressure with the opposing hand to promote ease of dissection along the vessel 
Division of branches: establish a regular sequence for dividing the branches,  consider making a 
fasciotomy  along the tunnel if the space is very tight, before dividing the branch consider whether it is 
of adequate length to clip or tie, keep energy settings as low as possible during branch division 
Vessel removal and preparation: make sure all branches and connective tissue are free from the vein 
before removing it, use appropriate technique for distal ligation of the vessel, take care not to stretch 
the vessel when removing it from the tunnel, once the vessel is extracted and prepared, place it in the 
specified solution until ready for use in the surgery. 
 
VIII. 
Human Rights Issues and Informed Consent 
 
After a subject has been deemed eligible for the trial through screening, the research 
coordinator or site investigator will obtain informed consent from the subject.  After the clinical care 
team meets with the subject to discuss the CABG procedure the research coordinator at each site will 
introduce him/herself and explain the study to the subject and present the detailed consent form if the 
subject gives permission to discuss the research study.  The consenting process for the research study 
will occur at a separate time point, after the informed consent for clinical care has been completed.  
Subsequently, the site investigator or a designee will review and discuss the study with the subject and 
answer any questions that the subject might have.  The general purpose of the study, along with 
detailed information about the treatment comparisons, the randomization process, the study timeline, 
including what is expected of the subject, and the rights of study subjects will be clearly described.  The 
harvesting techniques (both EVH and OVH) and the associated risks with the techniques will also be 
addressed.  The importance of subject confidentiality will be stressed, and the process for maintaining 
confidentiality will be described. This discussion will be held in an area that provides the subject time to 
focus on reading information about the study and asking questions without feeling rushed or 
uninformed. Any family member the subject requests to be present will be included. At this time, the 
surgeon(s) participating in the study will also meet with the subject to discuss the study and answer any 
questions about the two different types of procedures for vein harvesting that might be performed. 
 
The site investigator or research coordinator will ensure that the subject understands every 
aspect of the trial, including its risks and benefits, prior to signing the informed consent. 
 
If the subject agrees, his/her consent to participate in the study will be recorded on the CSP# 
588 Informed Consent Form (VA form 10-1086, See Appendix A – Informed Consent Form).  The original 
will be kept in the site investigator’s study file for that subject and a copy will be placed in the subject’s 
 
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medical record.  Copies of the signed consent form will be provided to the subject, the Research Office 
at the participating site (if required by the IRB), and faxed or mailed via UPS/FedEx  to the Perry Point 
CSPCC at the time of enrollment in the study.   
 
Informed consent requires that the subject understand the details of the study and agrees, 
without coercion, to participation in the study. To obtain informed consent, the following information 
shall be provided to each subject:  
 
• 
Name of the study 
• 
Name(s) of the Site Investigators 
• 
Explanation that the study involves research 
• 
Explanation of the purpose of the study 
• 
Explanation of the treatment procedures 
• 
Description of randomization 
• 
Description of the risks and benefits of participation in the study 
• 
New findings that may affect willingness to maintain participation in the study 
• 
A description of alternatives to participation in the study 
• 
Explanation that all records will be kept confidential, but that records may be examined by 
representatives of the VA 
• 
Who to contact for questions about the research and about subjects’ rights 
• 
Who to contact in the event of research-related injury 
• 
A statement that participation in the study is voluntary and that a decision not to participate or to 
withdraw from the study after initially agreeing involves no penalty, loss of benefits or reduction 
in access to medical care 
• 
The consequences of a subject’s decision to withdraw from the study, and a description of the 
procedure for orderly termination of participation 
 
In conjunction with the informed consent procedure, subjects will review and be asked to sign 
the Authorization for Release of Protected Health Information Form as required by the Health Insurance 
Portability and Privacy Act (HIPAA). 
 
IX. 
Evaluation Procedures 
 
A. Screening  
 
The research study coordinator will be primarily responsible for identifying each non-emergent 
subject scheduled for a CABG-only procedure with planned SVG harvesting. A diagnostic catheterization 
must be performed within six months  prior to the scheduled operation to be used as part of the 
baseline assessments. The participating surgeon(s) must agree that the subject is eligible for either study 
arm before randomization based on the inclusion/exclusion criteria defined by the protocol. This 
includes a review of the medical history for any lower extremity issues that would prevent the harvest of 
an effective SVG such as varicose veins, etc. Following subject informed consent, the baseline risk 
assessment, clinical data and subject self-reported symptom status and health related quality of life data 
will be obtained by the study team.  
 
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B. Randomization 
 
All participating vein harvesters must meet the minimum EVH/OVH volume criteria [at least 100 
EVH cases with low conversion rates (<5%) as part of an EVH program established for more than two 
years] to be eligible to enroll subjects in this study. Unless an urgent medical condition exists, the 
subject’s surgery will be scheduled  to occur at the earliest possible date based on expert harvester 
availability and other center circumstances. The randomization procedure will occur after the 
participating expert harvester is assigned to the subject. Subjects will be randomized within the assigned 
participating harvesters to one of the two study harvesting technique arms (EVH or OVH). 
 
Recognizing that the subject’s assignment to a participating vein harvester will have already 
occurred, the study randomization to either EVH or OVH will be done by a telephone call to the Perry 
Point Cooperative Studies Program Coordinating Center (CSPCC).   A block randomization scheme will be 
used to randomize subjects in two treatment groups. A random sequence of block sizes will be used to 
reduce the chances of guessing future allocations.  
 
C. Subject Assessments 
 
Baseline assessments will be collected prior to surgery and randomization including Body Mass Index, 
Ankle-Brachial Index and Venous Clinical Severity Scale. Intraoperative assessments will be collected 
during the CABG procedure, 24 and 48 hours postoperatively as well as assessments at the time of 
hospital discharge or 30 days post-surgery, whichever occurs first. Subjects will return for a six-week 
clinic visit to assess the condition of their leg incision and healing status.  Any necessary medical care 
required will be administered per the Institution’s standard practice. 
 
Subjects will receive a phone call every three months for follow-up for events until subject 
termination.   Subjects will complete QoL surveys again at one year either by telephone or mail.  If the 
subject reports a major adverse cardiac event (e.g. MI, repeat revascularization) after discharge from 
the hospital, then records will be obtained for final adjudication. Ascertainment for death will include 
review of VA central databases.   
 
Following is a list of assessments/study details that we plan on collecting: 
 
 
 Screening Record:  To compare subjects screened (but not enrolled) to subjects enrolled in 
this study, a comprehensive screening assessment will be completed for all potentially eligible subjects 
scheduled to receive an on-pump CABG-only procedure at a participating center by the study research 
coordinator. 
 
 
Initial Assessment of Coronary Arteries:  A cardiac catheterization will need to be performed 
within six months prior to randomization into the REGROUP trial.  A local catheterization laboratory 
reading and a local clinical team assessment (of target vessels denoting those vessels planned to be 
bypassed) will be required.  SYNTAX score will be calculated for each catheterization.  In addition, the 
surgeon will be asked to describe a surgical plan indicating which bypass grafts are planned after 
reviewing the cardiac catheterization results.   
 
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 Subject Risk Characteristics:  To evaluate the impact of EVH vs. OVH procedures upon 
subject subgroups for a possible differential benefit,  clinical data elements  (i.e. height, weight, co-
morbidity data, functional status, previous heart problems), cardiac catheterization and angiographic 
data, operative risk summary data (including operative death data), operative data, resource data (i.e. 
date and times of hospitalization, operation began and operation ended), socioeconomic data, and 
laboratory information will be collected.  STS and VASQIP scores will be calculated by the site research 
coordinator with the oversight of the local site surgeon investigator. 
 
 
Intraoperative Assessment:    Details about vessels bypassed, including size and quality of 
conduits used, quality of target arteries and suture technique will be collected.   Intraoperative 
complications will be recorded during the first 24 and 48 hours post-surgery and will include 
intraoperative bleeding complications, use of new intra-aortic balloon pump or assist device, unplanned 
cardiac arrest, blood product usage, as well as other variables.  
 
 
Post-operative Lab and Diagnostic Test Evaluation:  Twelve-lead EKGs will be obtained on 
the first two post-op days as noted in the detailed data forms.  This isa routine test, commonly 
performed as part of usual postoperative clinical care for CABG patients.  In the event the 12-lead EKG 
indicates either new pathologic Q waves or a new Left Bundle Branch Block, cardiac biomarker  levels 
(preferably cardiac Troponin) will be collected from the subject every eight hours until a downward 
trend is seen. The peak cardiac biomarker  value and reference range (including the 99th percentile of 
the Upper Reference Limit- URL) will be collected on the postoperative data collection Form 6.  
 
 
30-Day Operative Mortality Assessment:  Subjects will be noted to have died in-hospital or 
discharged alive.  For subjects discharged alive, their vital status will be reassessed at 30 days post-
CABG. 
 
 
30-Day Morbidity Assessment:  The presence/absence of major post-operative 
complications that occurred prior to discharge or within 30 days of CABG will be recorded.  Leg wound 
healing assessments and infection data will also be collected at discharge.   
 
 
In-hospital Resource Use:  Several in-hospital indicators including operating room time, 
extubation time (with reintubation times noted), SICU length of stay, pre-operative and postoperative 
length of stay, and total blood product use (both intraoperatively and post-operatively) will be 
measured.  
 
 
 
 
See Schedule of Events below:
 
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Table 2.  Schedule of Events 
FORM 
SCREEN 
BASELINE 
(pre op) 
Visit 00 
INTRA OP 
 
Visit 00 
POST OP 
 
Visit 00 
DC- 
30 DAY 
Visit 01 
6 WK 
 
Visit 02 
3 MO 
 
Visit 03 
6 MO 
 
Visit 06 
9 MO 
 
Visit 09 
12 Mo 
 
Visit 12 
… 
Every 3 
Mo 
45 MO 
 
Visit 45 
49 MO 
 
Visit 49 
AS 
NEEDED 
00 – Screening Log 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
01 – Screening and Randomization 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
02 – Baseline  Information 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
03 – Seattle Angina Questionnaire 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
04 – VR-12 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
05 – Intraoperative Data Collection 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
06 – Post Operative Assessments 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
07 – Discharge Assessments 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
08 –Leg Incision Pain Questionnaire 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
09 – Leg Incision Pain 6 week  
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
10 – Leg Incision  Assessment 
 
 
 
 
X* 
X* 
 
 
 
 
 
 
 
 
11 – Mace Event (6 week) 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
12 – Phone Call Follow-up 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
13 – MACE Event Form 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
14 - Termination 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
15 - SAE 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
16 – SAE Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
17 – Harvester Experience 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
18 – Protocol Noncompliance 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
19 – Confirmation of MI by Local 
Site 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
20 – Confirmation of MI by Clinical 
Events Committee 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
21 – Cause of Death by Clinical 
Events Committee 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
86 - Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
* Form 10 is collected at two time points (discharge and 6 weeks), do not fax form until the six week assessment has been completed.
 
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X. 
Post-Discharge Follow-up Assessments 
 
A. Six Week Visit 
 
 
Subjects will be assessed for leg wound complications approximately 6 weeks post-surgery 
during a clinic visit (this visit will take place between 4 weeks to 8 weeks post-surgery). Problems and/or 
procedures related to their cardiac health (i.e., acute myocardial infarctions, revascularization 
procedures, or a clinically indicated cardiac catheterization) will be obtained, Self-assessment 
satisfaction survey will be repeated at this time as well as Quality of Life questionnaires.  Any necessary 
medical care required will be administered per the Institution’s standard practice. 
 
B. Interim Follow-Up 
 
 
  Every three months during the active follow-up period post-surgery, the site study 
coordinator will contact the study subjects by telephone to determine whether they have experienced 
any problems and/or procedures related to their cardiac health (i.e., acute myocardial infarctions, 
revascularization procedures, or a clinically indicated cardiac catheterization).  These interim calls will 
collect MACE data, maintain rapport with subjects and let them know that the study team at the sites is 
interested in their progress.  At one year the subject will complete QoL surveys by telephone or mail. 
 
C. Monitoring Serious Adverse Events 
 
a.  Role of the Local Site Investigator in Reporting Serious Adverse Events (SAE)  
 
 
 
The local site investigator is responsible for following CSP reporting requirements: 
• 
Complying with the study procedure for reporting serious adverse events;  
• 
Reviewing the accuracy and completeness of all SAEs reported; and 
• 
Closely monitoring research subjects for any new SAEs. 
 
b. Study Intervention 
For the purpose of this study, the intervention for this study is defined as the vein 
harvesting procedure for a saphenous vein graft in coronary artery bypass. 
 
c. Definition of a Serious Adverse Event (SAE)  
A serious adverse event is an adverse event that results in one of the following 
outcomes: 
• 
Result in death;  
• 
Is life-threatening;  
• 
Requires inpatient hospitalization or prolongation of existing hospitalization;  
• 
Results in a persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life functions;  
• 
Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon 
appropriate medical judgment, they may jeopardize the subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in 
this definition; 
 
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• 
SAEs will be reported regardless of their relationship to the study intervention. 
 
d. SAE Monitoring and Reporting 
Research subjects will be monitored at each study contact (i.e., phone call and follow-up 
clinic visits).  Serious adverse events will be collected and recorded on the appropriate 
electronic case report form.  Active monitoring of SAEs will begin as soon as a research 
subject signs the Informed Consent and will continue through end-of-study for each 
subject.   
 
Serious adverse events require expedited reporting.  Expedited reporting is defined as 
the completion and submission of the appropriate electronic case report form to the 
study’s DataFax system within three (3) business days of the Local Site Investigator 
being aware of the SAE.  The Study Pharmacist (or designee) is responsible for 
evaluating all SAEs for subject safety concerns by the close of business the next day after 
receipt of the SAE.   
 
e. Reporting Serious Adverse Events to the Data Monitoring Committee (DMC)   
 
The Perry Point CSP Center and CSP Clinical Research Pharmacy Coordinating Center will 
prepare aggregated SAE reports for the DMC annually or on a schedule set by the 
Committee.   
 
D. Missed Visits 
 
 
If the subject fails to come to the clinic for the six-week follow-up visit, the research 
coordinator at the site will call the subject on the same day or, at the latest, the next working day to 
inquire about the reason for the missed visit and to reschedule the subject’s appointment as soon as 
possible.  The research coordinator will continue trying to contact the subject until the subject receives 
an appointment or formally withdraws from the study.  If the subject still refuses, the research 
coordinator will try to complete as much of the six-week assessments as possible on the phone by 
interview and/or by mail (e.g., the VR-12, Seattle Angina Questionnaire). 
 
E. Termination 
 
 
All subjects will be followed up actively until the sites are decommissioned.  After the six-
week clinic visit, each subject will be contacted by phone, every three months, to collect information on 
any MACE event, leg wound status, etc.  If the subject cannot be contacted, his/her CPRS records will be 
assessed to check for any MACE event.  If the subject dies or refuses to continue participation, he/she 
will be terminated.  A termination form will be used to record the termination information for these 
subjects.  At the end of the active follow-up phase (approximately 4.5 years from study start-up) each 
 continuing subject’s status will be recorded in a termination form to indicate official termination of the 
active follow-up phase of the study.   
 
 
All subjects terminated from the active follow-up phase of the study will be continually 
followed by the study’s national nurse coordinator where existing VA administrative databases will be 
mined for MACE for another two years (passive follow-up phase). 
 
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XI. 
Quality Control Procedures 
 
A. Standardization/Validation of Measurements 
 
 
Prior to the start of the study enrollment, all of the site investigators, harvesters and 
research coordinators will be provided with in-depth trainings on different aspects of the conduct of the 
study during a “kick-off” meeting to ensure proper understanding of the technical aspects of the 
protocol, to ensure uniformity in the completion and submission of the case report forms and to ensure 
uniformity in implementing and performing the study procedures. 
 
 
During this meeting, the site investigators and harvesters will receive a half-day of Good 
Clinical Practices (GCP) training and the research coordinators will receive one day of GCP training.  If 
any of the research coordinators from the participating sites is unable to attend the kick-off meeting, a 
repeat GCP training will be arranged. The GCP trainings will be provide by the SMART team from the 
Pharmacy Coordinating Center, Albuquerque, New Mexico. In any event, until this training is completed, 
the sites will not be allowed to begin randomization for the study. 
 
 
Site investigators and research coordinators will also receive informed consent and study 
procedures training by the Perry Point Cooperative Studies Program staff during the kick-off meeting.  
The Perry Point Nurse Coordinator will provide a more detailed training on the study specific informed 
consent procedures.  Other Perry Point Coordinating Center Staff will provide training on study 
procedures including the use of the study SharePoint portal, data collection on the DataFax platform, 
randomization and assessment schedules.  Specific training sessions will be as follows: 
• 
Study Procedures and Definitions 
• 
EVH/OVH Best Practices 
• 
Serious Adverse Event Reporting 
• 
Strategies for subject contact and follow-up visits 
• 
Data capture using DataFax 
 
B. Subject Management 
 
This research study will be conducted in full accordance with ethical principles of human 
research, including the provisions of the World Medical Association Declaration of Helsinki. 
All CABG subjects will be screened for study eligibility using the same inclusion/exclusion criteria as 
defined in this protocol.  Those subjects who qualify will be engaged in the study consent process by the 
clinical care team in collaboration with the research coordinator and led by the surgeon investigator.  
For those who agree to participate, local sites will adhere to their institution’s established best clinical 
practices in the care of the CABG subjects with exception to allowing for randomization of the 
harvesting technique at the time of surgery.  Quality of life questionnaires will be completed at baseline, 
at six-week and at one- year post CABG.  Subjects will be followed throughout their surgery and at 
discharge for research data collection including any serious adverse events (e.g. major adverse cardiac 
events).   The subjects will be monitored the first and the second day post-operatively with 12-lead 
electrocardiograms .  Per standard clinical care and most recent guidelines [Thyegesen 2012], cardiac 
biomarkers (preferably cardiac Troponin I or T) will be obtained if the 12-lead EKG demonstrates 
 
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evidence of type 5 [Thyegesen 2012] myocardial infarction, including new pathologic Q waves or new 
Left Bundle Branch Block.  The cardiac biomarker will be obtained every eight hours until a downward 
trend is seen in the level.  Usual inpatient post-operative care will follow institutional standards.  
Information on subject satisfaction and leg wound complications will be obtained at discharge and six 
weeks post-CABG.  Local site coordinators will contact the subjects every three months to collect 
information by phone regarding the subject’s health status throughout the active follow-up . 
 
Subjects will be encouraged to seek medical attention as instructed upon discharge from the 
hospital.  All efforts will be made to obtain follow-up information on subjects who have visited a 
hospital, underwent procedures or have been treated for serious adverse events in a non-study-related 
hospital(s).  Non-study hospital related materials will be collected and reviewed at the study 
coordinating centers.   
 
Throughout the duration of the study participation, the subject will be encouraged to 
maintain a point of contact with the local site investigator and the study coordinator for research 
related activities and questions. The study team at each site will maintain a dedicated point of contact 
for all subjects seeking information during their study participation. The study coordinator at each site 
will communicate any necessary medical information to the surgeon investigator and the clinical care 
team.   
 
 
Long-term secondary MACE outcomes will be collected by passive follow-up using VA databases 
for an additional two years after the completion of the active follow-up phase. 
 
C. Protocol Non-compliance 
 
 
Any protocol non-compliance will be reported immediately to the Chairman’s office and the 
Perry Point CSPCC.  Each of these groups then reserves the right to forward notification, as required by 
local policy and regulation.  Examples of protocol non-compliance include failure to obtain informed 
consent, failure to adhere to exclusion criteria, failure to report a serious adverse event, or no surgery is 
performed after randomization etc.   
 
D. Site Performance Monitoring 
 
In order to assure the successful conduct and completion of this study, all sites must adhere to 
certain performance standards.  The Perry Point CSPCC and the Chairman’s Office will jointly set 
performance standards and monitor site activities to assure that these standards are met. 
 
All cooperative studies are on probation during the first year of enrollment.  Studies that do not 
recruit at least 90% of the target enrollment during the first year are in danger of having monetary 
support stopped. 
 
In order to meet the target enrollment, recruitment activities at the participating sites will be 
monitored aggressively.  The Perry Point CSPCC will issue monthly recruitment reports to the Executive 
Committee and the Chairman’s Office.   The study Chair will contact the underperforming sites to 
identify problems and to recommend solutions. 
 
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XII.   DATA MANAGEMENT AND CASE REPORT FORMS 
 
A.  Assessments, Case Report Forms (CRFs) and their Frequency of Administration and Collection   
 
Please refer to Table 2 for a list of assessments and their frequencies of administration and 
collection.  
 
B. Data Collection and Data Entry 
 
Data management will be performed by the VA CSPCC Perry Point, MD using DataFax, a data 
management software.   The CSPCC will have overall responsibility for the data at the end of the study. 
 
All data will be collected at the study sites on source documents, which will be entered at the 
site into paper CRFs.  The blank CRFs will be supplied by the VA CSPCC Perry Point, MD.  CRFs are to be 
completed on an ongoing basis during the study.  The medical chart and the source documents are the 
source of verification of data.  CRFs should be completed according to the instructions in the study 
operations manual.  The local site investigator is responsible for maintaining accurate, complete and up-
to-date records for each subject.  The local site investigator is also responsible for maintaining any 
source documentation related to the study, including any films, ECG tracings, computer discs or tapes. 
 
Completed CRFs will be faxed by center personnel on a regular basis to the DataFax system at 
the VA CSPCC Perry Point, MD.  DataFax allows the clinical centers to retain the original CRF and source 
documents while providing a faxed image to the VA CSPCC.  Data within the faxed image are then 
checked for accuracy/completeness and entered into the study’s database using DataFax software.  Data 
received at the VA Perry Point CSPCC will be reviewed, verified and edited before being entered into the 
main study database.  If incomplete or inaccurate data are found, a data clarification request will be 
forwarded to the clinical site for a response.  Sites will resolve data errors before refaxing the corrected 
CRFs to the VA CSPCC.  All corrections and changes to the data will be reviewed before being entered 
into the main study database.  The VA CSP, Study Chair and the participating sites will receive reports at 
least monthly regarding the quality and quantity of data submitted to the VA Perry Point CSPCC. 
 
Site investigators agree to routine data audits by the staff of the VA CSP monitoring unit, as well 
as by the CSPCC staff.  The VA CSP monitors will routinely visit each site to assure that data submitted on 
the appropriate forms are in agreement with source documents at the sites.  They will also verify that 
subject informed consent for study participation has been obtained and documented in the subject’s 
progress notes, all essential documents required by GCP regulations are on file, and sites are conducting 
the study according to the research protocol.  Any inconsistencies will be resolved, and any changes to 
the data forms will be made using established VA CSPCC Perry Point procedures. 
 
When the study is completed and all data have been entered into the clinical database and the 
database has been checked for quality assurance and is locked, the CSPCC statisticians will perform 
statistical analyses of the data in accordance with the Statistical Analysis Plan (SAP).  Periodically, during 
the study, CSPCC will prepare various summary reports of the data so that progress of the study can be 
monitored.  These reports will be prepared for the Data Monitoring Committee (DMC) and other 
committees, as appropriate. 
 
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C. Study Documentation and Records Retention 
 
 
Study documentation includes all paper CRFs, data clarification forms, source documents, 
monitoring logs and appointment schedules, investigator correspondence and regulatory documents 
(e.g., signed protocol and amendments, IRB correspondence and approved consent form and signed 
informed consent forms, Statement of Investigator form, etc.).  
 
 
Source documents include all recordings of observations or notations of clinical activities 
and all reports and records necessary for the evaluation and reconstruction of the study.  Thus, source 
documents include, but are not limited to laboratory reports, subject completed assessments, progress 
notes, hospital charts or pharmacy records and any other reports or records of any procedure 
performed in accordance with the protocol. 
 
 
Whenever possible, the original recording of an observation should be retained as the 
source document; however, a photocopy is acceptable provided that it is a clear, legible, and exact 
duplication of the original document. 
 
 
Research records for all study subjects including medical history and physical findings, 
laboratory data, and results of consultations with the primary care physician are to be maintained by the 
investigator in accordance with the VA record control schedule until notified by CSPCC.  These records 
are to be maintained in compliance with IRB, State and Federal requirements, whichever is longest. It is 
the investigator’s responsibility to retain copies of the completed CRFs until notified in writing by CSPCC 
that they can be destroyed.  In all instances, the site must get permission from CSPCC prior to 
disposition of any study documentation and materials.  
 
 
All records with identifiers will be stored indefinitely in accordance with the VA Records 
Control Schedule. 
 
D. Data Security Plan 
 
To maintain subject confidentiality, all data submitted to CSPCC for the current study will be 
coded using alpha-numeric identifiers only.  Only on-site research staff and the sponsor’s delegated 
program officials will have access to records that may identify subjects.  Paper research and clinical 
records will be stored on site in a locked cabinet in a secure location.  Electronic records will be 
accessible only by data management staff, clinical monitors and active site personnel who have 
furnished the required training and credentials.  Permissions will be maintained by the CSPCC data 
management staff and can be revoked at any time.    Subject information will not be released without 
written permission, except as necessary for monitoring by the FDA, the VA CSP monitoring unit or the 
Sponsor.  
 
By participating in this protocol, the local site investigator agrees that within local regulatory restrictions 
and ethical considerations, the Sponsor or any regulatory agency may consult and/or copy study 
documents in order to verify data. 
 
 
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All data collected for this study will be handled and used in compliance with both the VA and the 
CSP data security plans.  All subject level data will be treated as protected health information.  Study 
personnel at CSPCC and at participating sites will be required to complete annual training courses.  
These courses will cover good clinical practices, human subjects’ protection, cyber security, and privacy 
policy.  Any data security breaches will be immediately reported.    Subject level data will never be 
stored on portable storage devices unless it is encrypted, explicitly authorized, and use specific. 
 
All private information will be kept on an encrypted, password protected server to which a small 
number of people will have access. Access to the cross-walk file linking the subject’s identifiers and their 
study data will be restricted to the clinical site and to the approved personnel at the Chair’s Office and 
Coordinating Center. This file will be destroyed according to CSP policy. 
 
All data will be stored within the VA firewall and will be password protected at all times. Hard 
copy data will be sent via a traceable mail system (i.e., UPS), via a courier, or via secure fax.  Access to 
these secure fax servers is restricted to the VA Perry Point coordinating center personnel with approved 
access to the system. All secure fax servers are compliant with VA directive 1605.1 and 6500. All data 
security incidents will be reported in accordance with VA policy within one hour of discovering the 
incident to: 
• 
The District (local) Information Security Officer (ISO) 
• 
The VA Perry Point CSPCC Data Security Officer 
• 
The local IRB. 
 
Administrative and healthcare utilization data on consenting participants will be extracted from the VA 
national database resources. The VA national data resources include, but are not limited to: the National 
Patient Care Database (OPC, PTF), VA-Medicare/Medicaid merge, national Laboratory and Pharmacy 
extracts (DSS, PBM), Corporate Data Warehouse (Health Data Repository), Medical Domain Web 
Services (MDWS), Patient Care Services Clinical Data Warehouse, Surgical Care Improvement Project 
(SQIP), Surgical Quality Workflow Manager (SQWM), VA Computerized Patient Record System (CPRS), 
Veteran Informatics and Computing Infrastructure (VINCI), VHA Support Service Center (VSSC), VA 
Surgery Quality Improvement Program (VASQIP), and the VA Vital Status File. Additionally, IT and 
Informatics initiatives to build the tools that will allow electronic medical record data extraction are 
being developed and will be used to obtain VISTA-level data to enhance the breadth of information and 
disease characterization that is lacking in the current national databases. This data will be 
downloaded/transferred with the appropriate permissions for use of these VA national databases, or 
individual VA Medical Centers, to the VA Central Research Database. 
 
E. Data Sharing Plan 
 
 
After the main results of this study have been published, de-identified data from this 
study may be shared with other VA investigators, other Federal health agencies, or academic institutions 
for the purpose of additional analyses provided this use has been approved by the appropriate VA 
oversight committee and there is an agreement in place that defines the limits of this use. 
 
 
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XIII. 
Feasibility of the study within the VA System 
 
As seen in the sample size section, approximately 1,150 subjects will be required for this study. 
It is believed by the Planning Committee that 16 participating centers recruiting over a 3 year period 
could enroll this number of subjects. Each center would be required to recruit a minimum of 72 subjects 
over the three year recruitment period. This amounts to 24 subjects per year or two per month. This 
level of two subjects per month is what the Planning Committee decided was reasonable to expect for 
the sites. We have successfully identified 16 high CABG volume (>100 CABG/year) cardiac surgery 
centers in the VHA with prior experience in CSP studies and experience in EVH/OVH procedures who are 
willing to join our study. In addition, at least five centers can be available to replace any center that 
would not be able to participate.  
 
 From October 1, 2008 to September 30, 2009 (Fiscal Year 2009) 3,952 CABG-only procedures 
were performed in 40 cardiac surgery centers in the VHA. The average number of CABG-only procedures 
per site was 99/year or 8/month. Based on the REGROUP Trial inclusion/exclusion criteria, a screening 
log was maintained for a six month period (June to December 2011) at the Cardiac Surgery Program at 
the West Roxbury, Massachusetts VAMC: an average of 4 CABG subjects/month were found to be 
eligible for inclusion in the study or 50% of CABG procedures. Recent CSP CABG studies, such as CSP 
#474 (Radial) and CSP #517 (ROOBY), successfully randomized an average of 2 subjects per center per 
month while enrolling only isolated CABG subjects and excluding subjects with unsuitable coronary 
targets.  We conclude that it is reasonable to assume that each of the 16 sites participating in CSP 588 
will enroll two subjects/month. All 16 selected sites have performed at least 100 CABG/year for two 
consecutive years, contributing to an average of 1600 CABG/year in the 16 sites. To recruit the 384 
subjects per year required for our study, 23% of this average number of CABG procedures will need to 
be entered into the study. Assuming conservatively that for the individual centers, the percentage of 
eligible subjects to recruit will be approximately 30-35% of all CABG procedures. Based on the limited 
inclusion/exclusion criteria, the sample size goal is perceived by the Planning Committee to be 
achievable. 
 
XIV. 
Requirements for Participating Centers 
 
All participating centers must be able and willing to adhere to the study protocol. The minimum 
requirements for participating medical centers include: 
 
• 
Site Principal Investigator: Each center must identify their site’s principal surgeon investigator 
who enthusiastically supports the study and is willing to devote sufficient time and energy to 
ensure that the study’s goals are met. For VA medical centers, the site surgeon investigator 
must have at least a 5/8ths VA appointment for receiving VA research funds. 
 
• 
EVH/OVH Harvester:  Each center/study surgeon investigator must identify their site’s 
harvester(s).  The harvester(s) must have performed a minimum of 100 EVH procedures with a 
conversion rate to OVH < 5%to qualify for participation in the REGROUP trial. Each harvester 
must also demonstrate competency in OVH or the study surgeon investigator directly attending 
the case must perform the OVH in the same manner as provided during the course of usual care  
 
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absent a clinical trial.  A subcommittee of the Executive Committee will convene and review 
each site’s harvester qualifications and issue guidance/recommendations for sites as needed. 
 
• 
Enrollment Volume: Each center must provide documentation that it will be able to recruit 24 
subjects receiving a CABG-only procedure per year into the study who meet all 
inclusion/exclusion criteria. This total will be 72 subjects receiving CABG-only procedures over 
the three-year recruitment period. 
 
• 
Administrative Support: Each center must provide assurance by the Chief of Surgery Service 
and/or the Chief of Staff that their site investigator will receive full administrative support.  
 
• 
Multiple Participating Surgeons: At each center, there should be at least one (and preferably 
two or more) cardiothoracic surgery attending faculty team members participating that agree to 
randomize and operate on all consenting, eligible subjects with a planned CABG-only on-pump 
procedure using a median sternotomy incision.  Although participating surgeons may 
enter/leave the study (after approval by the Chairman’s office and Perry Point CSP Coordinating 
Center), the center must make every effort to recruit and to retain at least one qualified 
participating surgeon to enroll subjects in this study. 
 
• 
Local Approvals and Reporting Required: Acceptance and approval of the protocol and the 
informed consent document with only minor changes by the site investigator, the local VA 
medical center’s R&D Committee, and the local IRB. Copies of the meeting minutes indicating 
approval by the local R&D Committee must be submitted to the Perry Point CSP Coordinating 
Center prior to enrolling subjects at the local center. 
 
• 
Global Monitoring and Reporting Responsibilities Delegated: By agreeing to participate in the 
study, centers delegate responsibility for global monitoring of the ongoing study to the Data 
Monitoring Committee, the Cooperative Studies Scientific Evaluation Committee (CSSEC), the 
Institutional Review Board, and the Perry Point CSP Coordinating Center. However, the local 
Research and Development Committee and the local IRB of the center will require the site 
investigator to submit annual reports concerning the status of the study for local monitoring 
purposes. 
 
• 
Research Study Coordinator:  The site investigator must make every effort to recruit and retain 
an enthusiastic research study coordinator, preferably one experienced in clinical trials, who will 
work diligently with the site investigator to meet the study’s goals.  Moreover, this local study 
coordinator must work collaboratively with the Chairman’s office staff, including the National 
Nurse Coordinator. 
 
 
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XV. 
Study Organization Administration and Monitoring 
 
A. Monitoring Bodies 
 
 
The groups charged with monitoring the various aspects of the study will be the Executive 
Committee, the Data Monitoring Committee (DMC), and the local site IRBs.  These committees will meet 
at regular intervals according to the current Cooperative Studies Program guidelines:  prior to the 
beginning of subject enrollment and at least every twelve months thereafter.  In addition, the CSP Site 
Monitoring, Auditing and Review Team (SMART), located at the CSP Clinical Research Pharmacy 
Coordinating Center (CSPCRPCC), will monitor the trial for GCP compliance. 
 
 
 
The Executive Committee is the management and decision-making body for the operational 
aspects of the study and will monitor the performance of participating medical centers and the quality 
of data collected.  The Executive Committee will formulate publication plans and will oversee the 
publication and presentation of all data from the study.  The Committee must grant permission before 
any study data may be used for presentation or publication. 
 
 
The Data Monitoring Committee (DMC) will review the progress of the study and will 
monitor subject intake, outcomes, serious adverse events, and other issues related to subject safety.  
The DMC makes recommendations to the Director of the Clinical Science Research and Development 
(CSRD) Service about whether the study should continue or be stopped.  The DMC will consist of experts 
in the fields of Endoscopic Vein Harvesting, Cardiothoracic Surgery, Cardiology, clinical trials, 
biostatistics, and ethics.  These experts will not be participants in the trial and will not have participated 
in the planning of the protocol.  The DMC will consider safety or other circumstances as grounds for 
early termination, including either compelling internal or external evidence of treatment differences or 
the unfeasibility of addressing the study hypothesis (e.g., poor subject enrollment, poor adherence to 
protocol). 
 
 
At each of its meetings during the study period, the DMC will review the randomization 
rates and assess the difference between the actual and the projected rates, as well as the impact of 
these assessments on overall trial size.  An assessment of whether the trial should be continued will be 
made followed by recommendations, as appropriate.  All serious adverse events will be reported on a 
regular basis to the DMC for their review.  Unexpected serious adverse events may be reported to the 
DMC in an expedited manner based upon the consensus of the Study Chairman, the Study 
Biostatistician, and the Perry Point CSPCC Director.  The Study Biostatistician will provide the 
appropriate data to the DMC at specified intervals for this purpose. 
 
 
The Clinical Events Committee (CEC) will consist of one cardiologist and two cardiac 
surgeons who will meet semi-annually (either in person or via conference calls).  This committee will 
systematically evaluate all study deaths for cardiac versus non-cardiac causes.  The national nurse 
coordinator will prepare a Clinical Events packet for each subject death which will consist of notes, labs, 
tests from the subject’s medical record and death certificates or autopsy reports when available.  In 
addition, this committee will evaluate and confirm all reported myocardial infarctions (MI) using the 
published AHA/ACC/ECS Universal criteria (Thygesen 2007).  This may be accomplished using notes, labs 
and diagnostic tests from the subject’s medical record.  To assure compliance with data security 
 
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procedures, all necessary documentation will be “scrubbed” to remove subject identifiers and any 
reference to treatment arm received. 
 
 
The local sites IRB will be the study’s primary IRB and the IRB of record for the study.  It will 
be responsible for the initial and continuing IRB reviews of the study.  The local site IRB must review and 
approve amendments (changes to inclusion/exclusion criteria, protocols, informed consents, etc.), 
deviations, and review reports about serious  adverse events and problems, complaints, terminations, 
etc. and that the investigators must provide the local site IRB all supporting documentation.  The CSPCC 
will be responsible for providing the local site IRB with all materials that are required for each review 
and to respond to local IRB’s queries and requests for additional materials.  The local site IRB approves 
the original informed consent template and any requested changes to the informed consent forms. 
 
 
The Human Rights Committee (HRC) at the Coordinating Center will review the study prior 
to its initiation to the local site IRB to ensure proper protection of the subjects’ rights and safety.  The 
CSPCC HRC will also conduct at least one site visit during the study to interview study subjects to assess 
whether subject rights are being fully protected. 
 
 
CSP SMART will provide GCP training at the kick-off meeting and will conduct initiation visits 
at all sites.  It also will conduct a GCP site review and a for cause audit of a participating site if requested 
by any of the monitoring bodies.  At a minimum, each site will be visited at least once during the study 
by SMART.  The local site IRB will receive a copy of all SMART monitoring reports. 
 
 
The Quality Assurance Section at the Perry Point CSPCC will provide central monitoring of 
study sites to ensure compliance with Good Clinical Practice.  Monitoring may include but is not limited 
to the informed consent process, data validation, source verification, and safety reporting.  Additional 
site-specific monitoring may be conducted if triggered by poor study performance.  Site performance 
findings may result in on-site visits by the CSPCC QA Nurse Specialist or other CSPCC central monitoring 
personnel to evaluate the need for additional site training to remedy compliance concerns. 
 
 
The Study Group, which consists of all site investigators, participating harvesters, and 
research coordinators, will meet annually to discuss the progress of the study and any problems 
encountered during the conduct of the trial. 
 
B. Monitoring Subject Safety 
 
 
The Perry Point CSPCC and CSPCRPCC will provide summaries of all serious adverse events 
reported to the Study Chairman and DMC at least twice a year. 
 
C. Monitoring Subject Intake and Probation or Termination of Participating Sites 
 
 
The Study Chairman and the Study Biostatistician will monitor the intake rate and 
operational aspects of the study.  Participating medical centers will continue in the study only if 
adequate subject intake is maintained.  The Executive Committee may take action leading to the 
discontinuation of subject enrollment at a center with the concurrence of the CSPCC Director.  If 
recruitment is not proceeding at an appropriate rate, the Study Chairman and Study Biostatistician will 
 
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scrutinize the reasons for inadequate subject participation.  Based on this information, the Executive 
Committee may choose to drop centers or add additional centers.  The DMC and Director of CSRD will 
be notified regarding the dropping or adding of centers.  Participating sites that do not enroll at least 24 
subjects during the first 12 months of the study will be placed on probation and given an opportunity to 
improve within a reasonable period.  After the first 12 months, participating sites that do not reach 75% 
of enrollment target during any six-month evaluation time will be placed on probation and given an 
opportunity to improve within a reasonable period.  If a medical center is placed on probation, the Study 
Chairman will confer with the site personnel and visit the site, if necessary, to help improve the rate of 
recruitment.  If there is no improvement in accrual during the probation period, the site may be subject 
to reduced funding or possible termination as a study site.  To plan for the possible termination of a 
site(s) and the addition of a new site(s), back up sites with IRB approval will be identified prior to study 
initiation to minimize the delay in adding a new site.  The Executive Committee will only take actions 
leading to discontinuation of a center with the concurrence of the CSPCC Director.  If a center is 
terminated from the trial, resources will be reallocated to other centers or used to start up a backup 
site. 
 
D. Alternate Plan if Recruitment Goals are not Met 
 
 
After the study has been in the recruitment phase for three months, the Study Chairman 
and the National Nurse Coordinator will contact the local site investigators and research coordinators to 
identify any common obstacles to subject recruitment and identify steps that might be taken to reduce 
those obstacles.  If recruitment has fallen short of anticipated goals by month six due to low CABG 
volume at the participating centers, the Study Chairman will make a proposal to the Executive 
Committee to alter the inclusion criteria from CABG only on-pump procedures to additionally include 
on-pump CABG plus valve procedures. 
 
 
E. Monitoring Medical Center Performance 
 
 
Each participating site will be monitored for data quality, completeness of follow-up and 
adherence to the protocol.  Regularly scheduled conference calls (at least monthly) with the sites, CSPCC 
and Chairman’s office will be held to address data collection, protocol procedures and other issues.  
Strict adherence to the protocol will be expected of every participating center and will be monitored by 
the DMC, the Executive Committee, and the CSPCC.  Documentation of protocol noncompliance will be 
required and any medical center with repeated protocol noncompliance issues will be recommended to 
the Executive Committee for termination.  If a participating site investigator feels that adherence to the 
protocol will in any way be detrimental to a particular subject’s health or well-being, the interest of the 
subject will take precedence over continued study participation.  In addition, CSPCC, the Executive 
Committee and the DMC will monitor protocol adherence centrally.  The Executive Committee will 
consider recommending a full GCP audit to be conducted by SMART for any site with repeated protocol 
noncompliance issues and will consider terminating the site from the trial. 
 
 
Data quality and completeness of data retrieval will be closely monitored on an ongoing 
basis by the Coordinating center.  The study biostatistician will present interim monitoring reports to the 
Executive Committee and the DMC that will include the following types of information: 
 
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• 
Subject intake 
• 
Randomization 
• 
Breaches of protocol 
• 
Adherence and compliance of study protocol 
• 
Missed study visits 
• 
Completeness of follow-up 
• 
Audit and site visit results 
 
 
If a site is identified as an outlier in terms of data quality, a site conference call or site visit 
will be initiated to assess the reasons why problems are occurring and how they can be corrected.  If the 
problems continue, the site may be placed on probation or terminated from the study. 
 
F. Monitoring of safety, efficacy and futility 
 
 
As previously noted, the DMC will review the accumulating data and be responsible for 
determining whether or not to recommend that the trial be stopped for efficacy, futility or safety.  Data 
summaries will be prepared for the DMC for these purposes.  Frequent summaries of serious adverse 
events will be prepared for the DMC for monitoring of safety, i.e., at least twice a year.  To aid the DMC 
in their deliberations, other relevant information specific to CSP# 588 will be made available.  Complete 
details of the interim monitoring plans for the study are given in Section XVII Biostatistical 
Considerations below. 
 
XVI. 
Good Clinical Practices 
 
A. Role of GCP 
  
 
This trial will be conducted in compliance with Good Clinical Practice (GCP) regulations.  The 
intent of these regulations is to safeguard subjects’ welfare and assure the validity of data resulting from 
the clinical research. The VA Cooperative Studies Program will assist Local Site Investigators (LSIs) in 
complying with GCP requirements through its Site Monitoring, Auditing and Resource Team (SMART) 
based in Albuquerque, NM.  SMART serves as the Quality Assurance arm of CSP for GCP compliance.  
Study site personnel will receive GCP training at the study organizational meeting.  SMART will provide 
training, manuals and materials to assist study personnel in organizing study files and will be available 
throughout the trial to advise and assist LSIs regarding GCP issues.  
 
B. Summary of Monitoring and Auditing Plans 
 
a. Monitoring Visits  
(1)  Initiation visits at each site soon after study start-up 
(2) Additional monitoring visits may be conducted as deemed necessary by study 
leadership or SMART. 
 
b. Audits  
(1) Routine audits – independent site visits to one or more sites per year as determined 
by SMART.  
 
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(2) For-Cause audits –independent audit of a site as requested by study leadership or 
CSP Central Office.   
(3) Audits may be scheduled or unannounced. 
 
XVII. 
Biostatistical Considerations 
 
A. Expected Treatment Effects 
 
 
In the ROOBY study (CSP # 517) (Shroyer 2009), one year MACE rates were 9.9% in the OVH 
group and 15.3% in the EVH group (p=0.0025). The executive committee for the REGROUP study 
assumes that during the REGROUP study, 15.5% of the subjects in the EVH group will experience MACE 
in the first year post surgery. The committee also expects a 6 percentage point improvement in the one-
year MACE rate  in the OVH group.  
 
B. Sample size calculation for the REGROUP study 
 
 
To detect the expected 6 percentage point difference in   one-year MACE rates between 
EVH (15.5%) and OVH (9.5%), a sample size of 545 in each group will be required at 85% power, 5% 
type-I error rate and with a two-sided test. A sensitivity analysis was also done with various scenarios 
which are shown in the Table 3. Since, it would be possible to capture the majority of the MACE from 
the VA databases even if the subjects drop out before the one-year clinic visit, a relatively small inflation 
factor of 5% is used to inflate the sample size to account for the drop-outs. Approximately, 1150 
subjects need to be randomized in the study to achieve the said power.  
 
  
Case 
1 
Case 
2 
Case 
3 
Case 
4 
Case 
5 
Case 
6 
Case 
7 
Case 
8 
Case 
9 
Tails 
2 
2 
2 
2 
2 
2 
2 
2 
2 
Proportion 1 (%) 
9.9 
9.9 
9.9 
9.5 
9.5 
9.5 
10 
10 
10 
Proportion 2 (%) 
15.3 
15.3 
15.3 
15.5 
15.5 
15.5 
16 
16 
16 
Alpha 
0.05 
0.05 
0.05 
0.05 
0.05 
0.05 
0.05 
0.05 
0.05 
Power (%) 
90 
85 
80 
90 
85 
80 
90 
85 
80 
Allocation ratio 
1:1 
1:1 
1:1 
1:1 
1:1 
1:1 
1:1 
1:1 
1:1 
Sample Size 
792 
677 
592 
637 
545 
476 
659 
563 
492 
Total Sample 
Size 
1584 
1354 
1184 
1274 
1090 
952 
1318 
1126 
984 
Attrition = 5% 
1667 
1425 
1246 
1341 
1147 
1002 
1387 
1185 
1036 
Attrition = 10% 
1760 
1504 
1316 
1416 
1211 
1058 
1464 
1251 
1093 
Attrition = 15% 
1864 
1593 
1393 
1499 
1282 
1120 
1551 
1325 
1158 
 
Table 3: Various sample size scenarios for the REGROUP study 
 
Based on the one-year MACE rate difference between EVH and OVH groups as obtained from CSP 517, if 
we assume at the end of the active follow-up period (approximately 4.5 years from the beginning of the 
recruitment process) difference in survival rates (i.e., the proportion of subjects who will not experience 
 
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MACE) between the two harvesting groups will be approximately 8 percentage point (i.e., 83.5% in the 
EVH and 91.5% in OVH), a sample size of 532 per group will be required to achieve a power of 97.5%. So, 
the sample size of 1150 (with approximately 7% attrition rate accounted for) will provide adequate 
power to the time-to-MACE event primary outcome.   
 
C. Duration of Study/Number of Participating Sites 
 
 
Based on the experience of previous CSP studies on CABG performed in the last decade 
(2000-2010) (e.g. CSP #517 ROOBY and CSP #474 RADIAL), a two subject/month/site enrollment rate 
was assumed to be a reasonable enrollment rate for this study. With this assumption, various scenarios 
were created to find an optimum balance between the number of sites, the study duration (which 
includes enrollment period and follow-up period) and the estimated budget. The chosen scenario was 
with 16 sites around the country where both EVH and OVH are currently practiced. With 16 sites and 
two subjects/month/site rate of enrollment, the enrollment period was found to be approximately, 
three years which would be followed by a minimum of one-year follow-up for the last subject 
randomized into the study. This will allow approximately 4 – 4.5 years of active follow-up of all 
randomized subjects followed by additional 2 years of passive follow-up using the VA databases.  The 
total duration for the 16 participating sites will be approximately 6.5 years.  
 
D.  Statistical Analysis Plan 
 
1. Intent-to-treat (ITT) analysis 
 
 
 
Intent-to-treat population is defined as the population of subjects who will be 
randomized to either of the harvesting technique groups – EVH or OVH. The subjects will be categorized 
(in terms of their harvesting technique group assignment) based on their initial randomized group 
irrespective of conversion before surgery and will be included in analyses irrespective of their status – 
completer or drop out of the study before completion. Analyses of all outcome measures – primary and 
secondary – will use ITT population.  
 
 
 
All statistical tests will be 2-sided and the primary MACE outcome will be tested at 5% 
level of significance. SAS will be used to conduct all the statistical analyses. 
     
2. Primary Outcome Measure 
 
 
MACE, the composite endpoint that includes Death (all cause), Myocardial Infarction 
(MI) and Revascularization for myocardial ischemia, will be the primary outcome measure after 
randomization and the index CABG. Each randomized subject (either in Endoscopic or in Open 
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 an MI or a revascularization procedure during the 
follow-up period. Total follow-up period will be 6.5 years of which the first 4.5 years will be active 
follow-up (using in-clinic visit or by telephone) period and will be carried out by the site personnel. The 
remaining 2 years will be passive follow-up which will be carried out centrally by the chair’s office staff 
using the VA patient database. A minimum of 1 year of active follow-up will be used for subjects who 
will be randomized at the tail end of the 3-year projected enrollment period of the study. The subjects 
 
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who will either be lost to follow-up or will not experience an ‘EVENT’ before the end of the follow-up 
period will be considered as right censored.  
The primary analysis of such time-to-Mace event data will include the events only from the 
active follow-up period (which is 4.5 years). The secondary analysis will include events from the entire 
6.5 years of follow-up period.  
Survival analysis techniques will be used to analyze the time-to-MACE event data for both 
primary and secondary analyses.  
Kaplan-Meier analysis, a nonparametric method, will be used to estimate the survival (not 
experiencing MACE) over time in the two harvesting groups and a log-rank statistic will be used to test 
the equality of the survival function estimates in the two groups (the null hypothesis).   
Cox’s Proportional Hazards models will be used to investigate the effect of harvesting technique on the 
time until MACE adjusted for other potential influential variables, such as, age, gender, harvester’s 
experience etc.    
 
3. 
Secondary Outcomes Measures 
 
One and Three-year MACE: This composite endpoint consists of  
i. 
Death (all cause); 
ii. 
Myocardial Infarction and  
iii. 
Revascularization for myocardial ischemia.  
Subjects who suffer any one of these three outcomes within the first  year or in the first three 
years after the index CABG will be counted towards calculating the proportions of subjects with MACE 
(yes/no) in each harvesting technique group – subjects with endoscopic vein grafting or subjects with 
open vein grafting. Only the first event will be considered as the MACE event. These two proportions will 
be compared using a chi-square test.  
 
Post-operative Leg Wound Complications: All subjects in both harvesting technique groups – EVH or 
OVH – will be examined for complications of the leg wound from harvesting at discharge and at six 
weeks post-surgery. Post-operative leg wound complication status (yes/no) will be recorded at discharge 
and at six weeks post-surgery. Proportion of subjects with leg wound complications will be computed for 
each treatment group and these proportions at each time point will be compared using chi-square tests. 
The impact of confounding variables, such as, BMI, diabetes status, smoking status, on the post-
operative leg wound infection will be analyzed using a logistic regression.  
 
Severity of Incisional Leg Pain: Severe leg pain, due to incisions made during vein grafting, data will be 
collected at discharge and at six-week post CABG. Proportion of subjects with severe pain (pain score 3 
and above = yes) at each time point will be compared using chi-square statistics.  
 
Quality of Life: QoL scores using VR-12 and Seattle Angina Questionnaire will be computed at baseline,  
six week, and 12 months post-surgery for the subjects in the two harvesting technique groups (EVH and 
OVH). Subjects in both groups will be categorized as “improved”, “no change” and “worse” based on 
their baseline scores. The proportion of subjects in these three categories will be compared between the 
two groups using chi-square statistics. The actual scores from these measures will also be used to 
compare subjects in the two harvesting technique groups using analyses of covariance techniques, 
where the baseline (pre-surgery) scores will be used as a covariate. 
 
 
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E.  Interim Monitoring 
 
  
An independent oversight committee, a Data Monitoring Committee (DMC), will be 
monitoring study progress at predetermined time points over the entire duration of the study. The 
committee will receive analyses of the primary outcome measures and the important secondary 
outcome measures on a routine basis. In general, this committee meets at six to nine months after the 
start of subject recruitment and yearly thereafter. So, in total, this committee will meet maximum four 
times during the four years of the study duration. The committee will receive reports about three weeks 
prior to their annual meetings and at six monthly intervals in between the annual meetings. Since the 
primary outcome measure (MACE) are times-to-MACE event, sufficient data for DMC’s first review will 
not be available until the study has been ongoing for at least 2 years. So there will be approximately 8 
interim analyses of the primary outcome measure based on which the DMC will decide on study’s 
continuation.  
 
F. Criteria for Study Termination 
 
 
When repeated significance tests are performed on accumulating data as part of a routine 
monitoring function, the overall type-I error rate is inflated and the probability of a false positive finding 
is also increased. A number of methods have been developed to provide guidance on study termination 
rules based on multiple looks on the primary outcome measures for the review committees while 
keeping the overall type-I error rate maintained at 5%. For example, Haybittle-Peto or Lan-DeMets 
group sequential boundaries will provide study stopping guidance/criteria for the DMCs to implement. 
An example of typical Lan-DeMetes boundary for six looks is illustrated in Figure 2. The DMC will make 
the final decision on the type of stopping rule that will be used for the REGROUP trial. 
 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2: Lan-DeMets group sequential boundary for eight interim looks 
 
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-5.86 
-4.14 
-3.38 
-2.93 
-2.62 
-2.39 
5.86 
4.14 
3.38 
2.93 
2.62 
2.39 
-8
-6
-4
-2
0
2
4
6
8
1
2
3
4
5
6
7
8
S
t
a
n
d
a
d
r
d
i
z
e
d
 
Z
 
 
Number of Looks 

 
 
 
This group sequential boundary is used as a guide for study termination at any interim look. 
If the z-statistic at any interim look falls outside either the lower or the upper boundary, then the study 
should be considered for termination.  
 
G. Handling of Missing Data 
 
 
Every effort will be made to minimize the occurrence of missing data, particularly for the 
primary and main secondary outcome measures. For the primary outcome (MACE), every effort will be 
made to contact the subjects over the phone every three months until subject termination.  In the event 
of a potential drop out, every effort will be made to capture the MACE data from the VA databases.  
       
H. Reporting of Any Deviations from the Original Statistical Plan 
 
 
A more detailed statistical analysis plan (SAP) will be generated which will include the details 
of each statistical analysis plan for each outcome measure along with the suggested table shells for any 
reports that will be produced during the study and at the end of the study. Any deviations in the 
statistical plan from the protocol will be specified in the SAP. Any deviations from the SAP will be 
specified in the main manuscript which will be prepared and published at the end of the study.  
 
XVIII. 
PUBLICATIONS 
 
A. Publication Policy 
 
 
It is the policy of the Cooperative Studies Program not to reveal outcome data to site 
investigators until the data collection phase of the study is complete.  This policy is meant to prevent 
possible biases that might affect data collection.  Members of the DMC will be reviewing outcome 
results to ensure that the study will be terminated early if a treatment is identified as prohibitively 
dangerous or if a definitive answer is reached prior to the scheduled study termination date. 
 
 
All presentations and publications resulting from this study will follow CSP policy as specified 
by the CSP guidelines.  The presentation or publication of any or all data collected by site investigators 
on subjects entered into a Department of Veterans Affairs Cooperative Study is under the direct control 
of the study’s Executive Committee.  No individual site investigator has the right to use the study’s data 
to perform analyses or interpretations, or to make public presentations or seek publication of any or all 
of the data without specific approval of the Executive Committee. 
 
 
The Executive Committee has the authority to establish any number of publication 
committees, which usually will comprise of subgroups of site investigators and some members of the 
Executive Committee, for the purpose of producing manuscripts for presentation and publication.  Any 
presentation or publication related to this study should be circulated to the Executive Committee for 
review, comments and suggestions at least four weeks prior to submission of the manuscript to the 
presenting or publishing body. 
 
 
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All publications must give proper recognition to the funding source and should list all study 
participating site personnel (not necessarily as authors of the manuscript).  If an investigator’s major 
salary support and/or commitment is from the VA, it is obligatory that the investigator lists the VA as 
his/her primary institutional affiliation.  Submission of manuscripts or abstracts must follow the usual VA 
policy; ideally, a subtitle states, “A Department of Veterans Affairs Cooperative Study.”  The CSP also 
requires that every manuscript be reviewed and approved by the CSPCC Director prior to submission as 
a final quality control step.  Mechanisms for appeal by an investigator will follow procedures defined by 
the VA Office of Research and Development. 
 
 
Participation in a Department of Veterans Affairs Cooperative Studies Program clinical trial is 
voluntary.  Any investigator who cannot accept these operational guidelines regarding publication policy 
should not volunteer to participate in the study. 
 
B. Planned Publications 
 
 
Primary publication:  Upon completion of the study, a manuscript will be prepared that 
focuses on the primary outcome, i.e. endoscopic saphenous vein harvesting vs. open saphenous vein 
harvesting MACE rates during the follow-up period. 
 
 
Other publications:  Other planned publications will include at least the following:  Quality of 
Life with EVH and OVH , leg wound complications, 1 and 3 year MACE. 
 
XIX. 
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630 
 
[Serruys 2009] Serruys PW, Morice MC, Kappetein AP, Colombo A, SYNTAX Investigators. Percutaneous 
coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J 
Med 2009;360:961-972 
 
[Serruys 2010] Serruys PW, Onuma Y, Garg S, et al. 5-year clinical outcomes of the ARTS-II. J Am Coll 
Cardiol 2010;55(1):1093-01 
 
[Sianos 2005] Sianos G, Morel MA, Kappetein AP, et al. The SYNTAX Score: an angiographic tool grading 
the complexity of coronary artery disease. Eurointerv 2005;1:219-227. 
 
[Shroyer 2009] Shroyer AL, Grover FL, Hattler B, Collins JF, McDonald GO, Kozora E, ROOBY Investigators. 
On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med 2009; 361(19):1827-37. [VA CSP 
#517 main manuscript] 
 
 
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[Smith 2011] Smith SC, Benjamin EJ, Bonow RO, et al. AHA/ACCF secondary prevention and risk 
reduction therapy for patients with coronary and other atherosclerotic vascular disease. 2011 update. A 
guideline from the American Heart Association and American College of Cardiology Foundation. 
Circulation 2011; 124:2458-2473. 
 
[Taggart 2006] Taggart DP. Coronary artery bypass grafting is still the best treatment for multivessel and 
left main disease, but patients need to know. Ann Thorac Surg 2006;82:1966-1975. 
 
[Thatte 2001] Thatte HS, Khuri SF. The coronary artery bypass conduit: 1. Intraoperative endothelial 
injury and its implication on graft patency. Ann Thorac Surg 2001;72:S2245-52 
 
[Tennyson 2010] Tennyson C, Young CP, Scarci M. Is it safe to perform endoscopic harvest? Interactive 
CardioVascular and Thoracic Surgery 2010;10:625-630. 
 
[Thygesen 2012]  Thygesen K, Alpert JS, Jaffe AS and the Joint ESC/ACCF/AHA/WHF Task Force for the 
Redefinition of Myocardial Infarction, Third Universal definition of myocardial infarction.  Circulation 
2012;126:2020-2035. 
 
[Van Diepen 2013] Van Diepen S, Brennan JM, Allen KB, Hafley GE, et al. No difference in 1-year vein 
graft failure or 5-year clinical outcomes between open and closed tunnel endoscopic vein harvesting 
devices: results from the PREVENT-IV trial. Proceedings, The Society of Thoracic Surgeons 49th Annual 
Meeting, Los Angeles, CA. January 26-30 2013, p. 310. 
 
[Yun 2005] Yun KL, Wu Y, Aharonian V, Mansukhani P, Pfeffer TA, Sintek CF, et al. Randomized trial of 
endoscopic versus open vein harvest for coronary artery bypass grafting: six-month patency rates. J 
Thorac Cardiovasc Surg 2005;129(3):496-503. 
 
[Williams 2012] Williams JB, Peterson ED, Brennan JM, et al. Association between endoscopic vs open 
vein-graft harvesting and mortality, wound complications and cardiovascular events in patients 
undergoing CABG surgery. JAMA 2012;308(5):475-484 
 
[Wjins 2010] Wijns W et al. Guidelines on Myocardial Revascularization. The task force on myocardial 
revascularization of the ESC/EACTS. Eur Heart J 2010;31:2501-2555. 
 
[Zenati 2011] Zenati MA, Shroyer AL, Collins JF, Hattler B, Ota T, Almassi GH, Amidi M, Novitzky D, 
Grover FL, Sonel AF. Impact of endoscopic versus open saphenous graft harvest technique upon CABG 
patient outcomes in the randomized ROOBY trial. J Thorac Cardiovasc Surg 2011;141:338-44 [VA CSP 
#517 subanalysis] 
 
[Zenati 2006] Zenati MA, Sonel A, Hattler B, Shroyer AL, Collins J, Messenger J, Baltz JH, Mohr L, Gabany 
JM, Novitsky D, Grover F.  Patency outcomes of aortic connectors.  Innovations 2006; 1(5):255-257 [VA 
CSP #517 subanalysis] 
 
[Zenati 2007] Zenati MA, Sonel AF, Bjerke R, Shroyer L, Collins J, ROOBY Investigators. Safety of Aprotinin 
in CABG Patients: Results of the VA multicenter prospective randomized ROOBY trial. Circulation 
2007;116(16):II-396[VA CSP #517 subanalysis] 
 
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41 
 

 
 
[Zenati 2012] Zenati MA, Biswas K,  Shroyer AL,  Gaziano JM, Quin J, Haime M, Bhatt DL. Long-term 
patency of vein grafts harvested endoscopically for CABG: a meta-analysis. J Am Coll Cardiol 
2012;59:E1450 
 
 
CSP #588 
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Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
42 
 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 1 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
INTRODUCTION 
You are being invited to take part in a research study that is being funded by the Department of 
Veterans Affairs (VA).  Before you decide to take part, you should know why the research is being 
done and how it will be performed.  There may be potential risks and benefits if you decide to 
participate.      
 
Please read this information closely.  If you wish, discuss this study with family and friends.   If there 
is anything that if you would like to understand better, ask to speak to someone from the study.  Take 
your time in deciding if you want to participate.  If you do decide to take part, we will ask you to sign 
the last page of this consent form.  This means that you received all of the information below, were 
able to ask questions and discuss concerns with a member of the study team, and would like to take 
part in the study.   
 
1. Purpose of study:  
You are being invited to take part in this research study because it has you need to have coronary 
artery bypass graft (CABG) surgery.  As part of this procedure, you will have a piece of vein removed 
from one of your legs.  This is called vein harvesting.  This research study will compare two methods 
of vein harvesting.  Both methods are commonly used and considered safe but it is not known if one 
method is better than the other.  We hope this study will allow us to learn if one method of vein 
harvesting improves the results of CABG surgery more than the other method.    
 
One method is called “open vein harvesting” (OVH).  In this technique, one or more incisions are 
made along the thigh and calf to remove a vein called the saphenous vein.  The incisions may vary in 
length.  With the OVH technique, the surgical team can avoid handling the vein more than necessary in 
removing it from the leg.  After the vein is removed, the incision are sutured closed.  The leg is 
wrapped in a large bandage that will be removed one or two days after the operation.  A scar will be 
visible after the leg heals.   
 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-1 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 2 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
The other method of removing the vein is called “endoscopic vein harvesting” (EVH).  This method of 
removing the vein is newer but has been used for over 10 years.  In this technique, a small incision is 
made either above or below the knee.  A small video camera, called an endoscope, is inserted into the 
incision.  Special instruments are then used to remove the vein through this small incision.  One or two 
smaller incisions are made either in groin or calf to help remove the vein.  The leg is also wrapped in a 
large bandage that will be removed one or two days after surgery.  The scar that is left by this surgery 
is smaller.  In some cases, the incision heals more quickly and is less painful.  Some studies have 
suggested that there are fewer wound problems when this method is used to harvest the vein. 
 
Because the EVH technique appears to allow the leg to heal faster and causes fewer scars, this is now 
the more common method of harvesting the vein.  However, surgeons have recently questioned if the 
EVH technique may injure the vein and cause it not to work as well over time.  Examples of how this 
might happen include the heat from the endoscope or pressure from the instruments used during the 
procedure.   
 
At the present time, it is not known if the EVH technique causes injury to the vein.  If EVH actually 
does injure the vein, it is possible injury that OVH will be a better method of vein harvest.  If OVH is a 
more gentle method of harvesting the vein, it may allow the vein to deliver more blood and oxygen to 
the heart which may be better for the long-term results of the CABG surgery. 
 
If you agree to participate in this research study you will allow the method of vein harvesting for your 
surgery to be randomly chosen – such as deciding by using the flip of a coin. You will have a 50/50, or 
an equal chance of receiving either the open or endoscopic method of vein harvesting.  To participate 
in this study, both you and your surgeon must agree that the method of vein harvest will be randomly 
picked on the day of surgery.  This is the only part of your surgery that will be randomly chosen.  
However, if you or your surgeon prefers one technique over the other and would like to choose which 
technique you will have, you cannot participate in the study.   
 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-2 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 3 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
There are no experimental devices or drugs that will be used in this research study.  The endoscopic 
devices used in vein harvesting are approved by the U.S. Food and Drug Administration and have been 
in use for several years.  The instruments will not be used in any experimental manner.   
 
This study will recruit approximately 1,150 research subjects from approximately 16 VA centers 
across the country.  This VA site is one of 16 VA centers selected.  Approximately 72 patients will be 
enrolled over three years at this site. 
 
The study is funded by the Department of Veterans Affairs.  The Chief of Cardiac Surgery at the VA 
Boston Healthcare System is in charge of the overall study (Study Chair).  The VA sites will work with 
the VA Cooperative Studies Program at Perry Point, Maryland to collect and analyze data from this 
study.  The surgeon performing your CABG procedure will oversee the vein harvest.  This surgeon is 
one of the surgeon investigators of this research study for the hospital where you are having surgery. 
 
2. Description of the study, procedures to be used, and how long it will last:  
This research study is expected last approximately six years.  Your active participation in the project 
may be as long as three years or may be as short as one year depending on when you enter the study. 
The study team may also collect information about you through electronic medical records and 
national public databases for the duration of the study. 
 
If you decide to take part in this study, this is what will happen: 
 
After signing this consent form, the surgeon investigator and study coordinator will review your 
records to confirm you are eligible to take part in the study.  This is called screening.  As part of the 
screening, the coordinator will look at your medical record.  This includes, but is not limited to, your 
past medical history, the results of exams and tests including your heart catheterization and the 
evaluation by your surgeons.     
 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-3 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 4 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
Before going to surgery you will be asked to complete two baseline questionnaires for research 
purposes.  This will take approximately 20 to 30 minutes.  These questionnaires will ask you about 
your activity levels and how you feel both physically and emotionally.  You will be asked to report 
about your personal feelings.  You may skip any of the questions that you do not wish to answer.  
 
You will also have blood pressure measurements of both arms and legs while lying on a table.  This is 
called an Ankle-Brachial Index (ABI) test. This test checks the general condition of your arteries by 
measuring the difference in blood pressure from your arms compared to your legs. This test will show 
if there is decreased blood flow to your legs that may cause your leg incisions to heal more slowly or 
have problems after surgery. The quality of your leg veins will also be measured with a scoring system 
called venous clinical severity score in which we look at the quality of your veins.  These two 
assessments will be performed at the same time and will take approximately 20 minutes to complete.  
These tests may be routinely performed for patients going to surgery but we will also collect and report 
this data for research purposes.   
 
On the day of your surgery in the operating room, and under the supervision of the surgeon 
investigator, you will be randomized (like flipping a coin) to have the vein removed using either the 
EVH or OVH procedure.  A member of the study team will call a phone number to obtain the 
randomization assignment.  This will take about 10 minutes and will happen just before your surgery 
begins.  You may or may not already be asleep with anesthesia.   After you wake up, you will be able 
to see what type of vein harvest you received.  It is possible that both methods may have been used in 
harvesting your vein. 
 
Once the randomization assignment is known, your CABG surgery will proceed as usual.  You will 
continue to receive the same care that you would receive even if you were not participating in this 
research study throughout your hospital stay.   
 
 The study team will collect information about you from your medical records during and after surgery 
until you are discharged from the hospital.  On the first and second day after your surgery, you will 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-4 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 5 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
have an electrocardiogram - also known as an EKG.  This test is routinely performed on CABG 
patients but the results will also be used for research purposes.  If the EKG indicates there is new 
damage to your heart, known as a myocardial infarction (MI), then approximately two tablespoons of 
your blood will be drawn to check cardiac biomarkers. This is because cardiac biomarker levels will 
become increased in the blood when there is new heart damage. This test will be repeated every eight 
hours only if the level is increasing.  Once it is determined the level is decreasing or remains in a 
normal range no further levels will be drawn.  This blood test will help determine if you have had any 
new damage to your heart.   Cardiac biomarker tests are  frequently performed on CABG patients but 
the results will also be used for research purposes.    
 
When you are discharged from the hospital, you will be asked to complete a survey that asks you about 
your leg incisions. When you return in 4-6 weeks for a follow-up visit to the cardiac surgery clinic, you 
will be asked to complete this survey again.  If you had a problem with your leg incisions or any 
unexpected illnesses you will be asked to provide further information to the study team.  If you were 
treated at a non-VA facility, you may be asked to sign an authorization for release of information from 
the treating facility.  You will also be asked to complete the same two questionnaires that you 
completed before your operation.  Overall, your follow up visit should take approximately one hour.   
 
After your CABG follow-up visit, the study coordinator will contact you by phone every three months 
and ask you questions about your health.  This call may be as short as five minutes or longer depending 
on how much has changed with your health status.  You may also be contacted at other time points to 
clarify any questions about your health status.  This will continue for at least one year and possibly 
longer depending on when you entered the study and your overall health.  The study team will also 
collect information about your health from existing medical records and several different databases.  
These databases are listed on the following page, in the Confidentiality section of this consent form.   
 
3. Reasonably foreseeable discomforts or inconveniences of the study:  
• Before surgery, you will have ABI measurements as described above (on page 3), which will 
involve the use of blood pressure cuffs.  The tight, squeezing sensation of the cuff on the arm or 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-5 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 6 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
leg is commonly uncomfortable.  To minimize this mild discomfort, a properly sized blood 
pressure cuff will be used. 
• You will have an electrocardiogram, or EKG, on the first and second day after your surgery.  
The pads used for the EKG may cause skin irritation and be uncomfortable when they are 
pulled off the skin.  The technician is trained to remove the pads carefully. 
• You will have blood drawn for the study.  The amount taken will be about 1-2 tablespoons.  
This blood work will be drawn at the same time as your regular postoperative labs from a 
catheter already in place from your CABG surgery so no additional needle stick is required.    
• You will be asked to complete questionnaires as a part of the study.  You may feel 
uncomfortable answering some of the questions asked on the survey.  You may refuse to 
answer any question that you do not want to answer. 
• You will be asked to return to this facility's cardiac surgery clinic for follow-up so your 
incisions can be examined.  This is standard for CABG patients but may be inconvenient if you 
live a far distance away from this VA facility. 
 
 
4.  Reasonably foreseeable risks of the study: 
This consent form only discusses the risks of the research study.  The risks associated with the CABG 
surgery, vein harvesting and anesthesia are not discussed in this consent form.  You should talk with 
your health care providers about risks of the operation.  Prior to surgery, the surgical team will discuss 
the risks of CABG surgery with you in detail.  This will include a review of risks associated with the 
two methods of vein graft harvesting.  An anesthesiologist will meet with you before surgery to discuss 
the risks of anesthesia, blood loss and blood transfusions.  If you are a female who could become 
pregnant, you will have a pregnancy test prior to receiving surgery and anesthesia.  This is standard 
care.  If you are found to be pregnant, you will not be able to take part in this study.                                                    
 
Both vein harvesting techniques that are being studied are used commonly for CABG surgery.  For this 
reason, randomizing to one technique over the other does not increase the risk of the CABG surgery.  
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-6 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 7 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
Risks that are associated with some of the studies for this research are presented below.  To understand 
the level of risk described below the following definitions are used: 
 Common - Occurs in 10-25% of people (10 to 25 out of 100 people)  
 Rare - Occurs in less than 1% of people (less than 1 out of 100 people) 
 Not serious - Not expected to cause lasting harm 
 Serious - Possibly causing serious or permanent harm  
• There is that an unauthorized person views your health care information.  This is called a 
breach of confidentiality.  This risk of possibly serious but is rare.  Steps will be taken to 
minimize this risk, as described in the Confidentiality section below.  
• There is a risk that, during transfer of your health information, incorrect health information is 
obtained.   This risk of possibly serious but is rare.  Steps will be taken to minimize this risk, as 
described in the Confidentiality section below.  
 
5. Expected benefits of study:  
There are no known direct benefits to you for being in this study. 
 
6. Other treatment available:  
You may decide to not participate in this study and undergo your CABG surgery with you or your 
surgeon deciding the type of vein harvest method you will have instead of being randomized.  
7. Use of research results and Confidentiality:   
Information collected for this research study will be kept confidential as required by law.  Results of 
the study may be published for scientific purposes, but your personal records and identity will not be 
revealed unless required by law.  A description of this clinical trial will be available on the website: 
http://www.ClinicalTrials.gov, as required by U.S. Law.  You can search this website at any time. 
 
Administrative and healthcare utilization data about you will be collected from several national VA 
databases. The VA national data resources may include, but are not limited to:  
• The National Patient Care Database 
• VA-Medicare/Medicaid merge 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-7 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 8 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
• National Laboratory and Pharmacy extracts 
• Corporate Data Warehouse (Health Data Repository) 
• Medical Domain Web Services 
• Patient Care Services Clinical Data Warehouse 
• VA Surgical Care Improvement Project 
• Surgical Quality Workflow Manager 
• VA Computerized Patient Record System 
• Veteran Informatics and Computing Infrastructure 
• VHA Support Service Center 
• VA Surgery Quality Improvement Program 
• VA Vital Status File 
 
Some of this information will be automatically transferred from the electronic medical record and 
existing databases to another.  In order to ease data transfer and ensure that the correct information is 
being transferred, information technology (IT) initiatives are being developed.  These developments 
will allow data to be exchanged more accurately and widely.  Some of this data will be downloaded or 
transferred within the VA national databases or individual VA Medical Centers to the VA Central 
Research Database to be analyzed.   
 
Healthcare information about you that is collected for this study may be shared with other VA 
investigators, other Federal health agencies, or academic institutions for research purposes.  Your 
personal information will not be included in this data sharing.  Before this data can be shared, it must 
be approved by a VA oversight committee and limits applied for the use of the data.    
 
Information about you is protected in the following way:   
Your research records will be kept indefinitely or until the law allows their destruction in accordance 
with the VA Record Control Schedule (www1.va.gov/VHAPUBLICATIONS/RCS10/rcs10-1.pdf).  Records 
will be destroyed, when allowed, in the following manner.  
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-8 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 9 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
• Paper records will be shredded   
• Electronic records will be destroyed in a manner in which they cannot be retrieved.  
 
 Your data will be entered into a data repository and used for future studies approved by an IRB.  This 
repository will be housed and protected by the same VA CSP Data Coordinating Center for the study 
in Perry Point, MD.     
 
Your research records will be entered into a protected database that will be kept indefinitely after the 
study is completed.  This is required by law.  This includes your social security number which will 
allow for proper identification in using national databases.  This information will be safeguarded as 
outlined by the Privacy Act and Freedom of Information Act. 
 
In order to protect your personal information, any paper records related to your involvement in this 
research study will be stored in a locked file cabinet in a locked room.  Only certain research 
personnel, including the local site surgeon investigator, research coordinator and the study chair, will 
have access to this data.  Any electronic data will be stored on secured VA computer drives.  Only 
authorized persons will have access to this data.    
 
8. New Findings:  
You will be informed of any significant new findings during the study that may affect you or change 
your mind about staying in the study.  
 
9. Special circumstances:   
You will not be required to pay for medical care and services related to this study but may be required 
to pay for other medical care and services that are part of your usual care and not related to the study. 
This may include co-payments related to other VA or non-VA services including but not limited to 
dental services, healthcare supplies, medicines, orthopedic or prosthetic appliances and domiciliary or 
nursing home care.     
 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-9 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 10 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
You will be compensated $50 when you present for your six week clinic visit for your time and effort 
while taking part in this study.  You will need to consent to the release of personal identifying 
information to the Fiscal Office of the VA Boston Healthcare System.  This includes your name, 
address, and social security number. It is required so we may provide this compensation.  If payment is 
made to you by the VA an IRS Form 1099 will be generated.  The Form 1099 will be generated 
regardless of the amount you are paid or whether you are paid by check or cash voucher. 
 
10. Rights of Recourse:  
In the event that you are injured as a result of your being in this research study, you have the right to 
receive medical care, including emergency treatment.   This care or treatment is governed by federal 
law and VA policy. You also have the right to file any legal action - for example, if you believe there 
was negligence in the conduct of the study.  
 
11. Study Monitoring:  
Your VA research and medical records may examined by persons approved for this purpose.  Examples of 
persons or groups that might access your information include the Human Studies Subcommittee of this VA 
facility, the Executive Committee and Data Monitoring Committee for the study and personnel from the 
VA Cooperative Studies Program (CSP).  Because this research study involves things that are regulated by 
the FDA they may choose to access and inspect your records.  There is also a CSP Site Monitoring, 
Auditing and Review Team that will monitor this trial for compliance.  Other federal agencies may access 
your records as needed for oversight.  Regardless, your healthcare information will only be accessible to 
authorized persons.     
 
 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-10 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 11 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
RESEARCH SUBJECT’S RIGHTS: I have read or have had read to me all of the above. 
 
The study person named below has explained the study to me and answered all of my questions. I have 
been advised of the potential discomforts and risks of this study. I have been told of other choices of 
treatment that I could have.  
 
I understand that if I have any medical questions related to this research study, I should call Dr. 
__________________________ during normal working hours.  
 
I understand that if I have any general questions about this research study, I should call Dr. 
____________________________________ during normal working hours. 
 
I understand that if I have any medical problems that might be related to this study during normal 
working hours, I should call Dr._______________________.  For any problems during non-
working hours that are urgent, I should call ______________ and ask the hospital operator to 
page the on-call Cardiac Surgeon.    
 
I understand that, if at any point during or after this study I have any questions about my rights 
as a research subject or I want to discuss problems, complaints, concerns, and questions about 
this research, obtain information or offer input, I may contact the Research Compliance Officer 
after hours at ____________________. 
 
I understand that my participation in this study is voluntary, that I do not have to take part in 
this study and that, if I do take part, I may withdraw from the study at any time. I also 
understand that, if I refuse to take part or if I decide to withdraw, I will not suffer any penalty, 
loss of rights, or loss of VA or other benefits that I have a right to receive.  
 
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-11 

 
Department of Veterans Affairs 
 
VA Research Consent Form 
         (PAGE 12 OF 12) 
 
Principal Investigator:  
Title: RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP  
Study Chair: Marco Zenati MD, MSc, FETCS  
Co-Investigator:  
 
 
 
 
 
I voluntarily consent to be in this study. I will receive a signed copy of this consent form. 
 
 
 
 
 
 
Subject’s Signature                                     Month    Day    Year                          Name (print) 
Signature of Person Obtaining Consent   Month    Day    Year                           Name (print)  
Signature of Witness                                   Month    Day    Year                           Name (print)  
Subject’s Name:  
 ,  
 
 
Last 
First 
Date: _________________ 
Soc. Sec. No.   __________________________________   
(If research requires documentation in the medical record in accordance 
with VHA handbook 1907.1 the entire SSN must be obtained.)  
 
VA FORM 
JAN 1990  
10-1086  
 
Subject’s Initials 
VA IRB #  
 
Approved:  
 
Expires:  
 
 
Form valid only if above completed 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
  
A-12 

 
 
 
CSP#588 REGROUP 
SITE (RESEARCH COORDINATOR) BUDGET 
36 Months Recruitment 
ONE YEAR FOLLOW-UP 
August 16, 2012 
BASED ON 2 PATIENTS ENROLLED PER MONTH PER SITE 
16 SITES 
  
3 Month 
Start Up 
FY 13 
Recruitment  
12 months 
FY14 
Recruitment 
12 months 
FY 15 
Recruitment 
12 months 
FY 16 
12 months F/U 
FY 17 
3 months 
close out  
FY 18 
TOTAL 
Research Coordinator 
GS 11 1.00 FTE  
$25,045.00 
$105,190.00 
$110,450.00 
$115,972.00 
$121,771.00 $31,965.00 
$510,393.00 
SALARY TOTAL 
$25,045.00 
$105,190.00 
$110,450.00 
$115,972.00 
$121,771.00 $31,965.00 
$510,393.00 
Supplies 
$1,500.00 
$1,500.00 
$1,500.00 
$1,500.00 
$1,500.00 
$0.00 
$7,500.00 
IT Equipment 
$2,000.00 
$150.00 
$150.00 
$150.00 
$150.00 
$0.00 
$2,600.00 
Patient Payment 
  
  
$3,600.00 
$3,600.00 
$3,600.00 
$0.00 
$10,800.00 
Annual Travel 
Meetings $1,000 per 
person 
$3,000.00 
$3,000.00 
$3,000.00 
$3,000.00 
$3,000.00 
$2,000.00 
$17,000.00 
GRAND TOTAL 
SUPPLIES/TRAVEL 
$31,545.00 
$109,840.00 
$118,700.00 
$124,222.00 
$130,021.00 $33,965.00 
$548,293.00 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
B-1 

 
 
 
CSP#588 REGROUP 
SITE (RESEARCH COORDINATOR) BUDGET 
36 Months Recruitment 
ONE YEAR FOLLOW-UP 
August 16, 2012 
BASED ON 2 PATIENTS ENROLLED PER MONTH PER SITE 
16 SITES 
 
Justification for Patient Payments: 
 
 
No payment for enrollment in this study will be provided.  However, a small 
payment ($50.00) will be provided to all participants returning for their six week clinic 
visit.  This payment is provided to assist the participant for time and travel expenses. 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
B-2 

VA COOPERATIVE STUDY #588 
 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
 
Guidance for the Definition of Type 5 Myocardial Infarction (MI related to CABG) 
 
 
The CSP#588 Executive Committee has recognized the need to clarify a working definition to be 
used in the REGROUP Trial for Myocardial Infarction (MI).  
 
The updated Third Universal Definition of MI published in 2012 was cited as a reference for the 
Executive Committee discussion [Thygesen 2012]. 
 
The purpose of this clarification for the definition of MI is to capture every and all MI events 
during the conduct of the study while minimizing the volume of site reports that do not meet 
the definition of MI. 
 
As a modification to the currently approved protocol, no cardiac biomarkers (including troponin) 
will be routinely required as a study procedure at any time point (including baseline or postop).  
The case report forms will have indicators for these tests and corresponding reference ranges to 
be captured only if performed for clinical purposes and are available in the medical record of a 
consented subject for CSP#588. 
 
Electrocardiograms (12 lead ECG) will continue to be required on post-op day#1 and #2 as stated 
in the currently approved protocol, however these are performed for clinical purposes at every 
site at these same time points (POD#1 and POD#2) regardless of the study protocol.  
 
ECG abnormalities that indicate the need for cardiac biomarker workup include new pathologic 
Q waves or new left bundle branch block. 
 
In the event an ECG abnormality as described above, or clinical suspicion, causes concern for MI, 
cardiac biomarkers will be obtained. This is standard clinical practice. Cardiac Troponin I (cTn I) , 
cardiac Troponin T (cTn T) or CPK-MB will be obtained every 8 hours until a downward trend is 
seen in the level. The preferred cardiac biomarker is cTn I. 
 
The troponin will be considered indicative of MI if the peak level > 10 x 99th percentile of the 
upper reference limit (URL)  in the first 48 hours after CABG. The existing principles [Thygesen 
Circulation 2012] for the universal definion of MI should be applied for the definion of MI > 48 
hours after surgery. 
 
The cardiac biomarker level does not stand alone in the diagnosis of MI for post-op CABG 
patients, it must be accompanied in the same setting with at least one of the following: 
o  12 lead ECG with new pathologic Q waves or new left bundle branch block, or 
o angiographic documented new graft or new native coronary artery occlusion, or 
o imaging evidence of new loss of viable myocardium or new regional wall motion 
abnormalities. 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
C-1 

 
In the event cardiac biomarker work-up and ECG interpretations do not provide a complete 
diagnostic profile to the satisfaction of the surgeon investigator, a transthoracic echocardiogram 
would be the next clinical step to ascertain if a true MI occurred as evidenced by a new regional 
wall motion abnormality, with the exception of the septal wall. 
 
For the purposes of this study, septal wall motion abnormalities (which are prevalent in the 
postoperative phase) are excluded from the Definition of MI. 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
C-2 

Introduction: 
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. Assessments will be collected at multiple 
time points including: intraoperatively, postoperatively, at discharge or 30 days after surgery if still 
hospitalized. 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 intervals 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. 
This study will enroll approximately 1150 subjects requiring CABG at 16 VA Medical Centers with 
expertise in both techniques of vein harvesting. Assuming an enrollment rate of two subjects/medical 
center/month, total enrollment will take approximately three years to complete.  With at least one-year 
follow-up period for the last subject randomized and two additional years of passive follow-up by the 
chair’s office, the total duration of the study will be approximately six and half years.   
 
Study Management at the CSPCC: 
A Cooperative Studies Program Coordinating Center (CSPCC) study team has been assigned to 
CSP 588, the REGROUP trial, for providing data management, statistical, and administrative supports to 
the study executive committee for a smooth conduct and timely completion of the study. The study 
team is comprised of: 
 
Biostatistician and Team Lead  
 
Kousick Biswas, Ph.D. 
 
Project Manager 
 
 
 
Annette Wiseman 
 
Statistical Programmer  
 
 
Rebecca Horney 
 
Database Programmer  
 
 
Christine Dalzell 
 
Computer Assistant 
 
 
 
Daniel Briones 
 
Computer Assistant 
 
 
 
Mike Beam 
Other core CSPCC staff, for example, Quality Assurance, Travel Clerk, Printer, Secretary, etc., will 
provide help based on the need of the study.     
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-1 

The Biostatistician is the study team leader and has the overall responsibility for the conduct of 
the study at the CSPCC. He is the CSPCC’s spokesperson to the Study Group; he represents the CSPCC on 
the study’s Executive Committee and along with the Study Chairperson, he is responsible for 
representing the study at the Data Monitoring Committee meetings. When un-blinded data are 
presented to the DMC, he is the only study representative allowed at those portions of the DMC 
meeting. The Biostatistician is also responsible for providing the Study Group with statistical and clinical 
trial advice, for working with other CSPCC team members in the preparation of routine interim reports, 
and for conducting the final analyses at the end of the study. 
The Project Manager is responsible for the administrative coordination of the study by the 
CSPCC. She serves as the Biostatistician’s Administrative Assistant and works with the CSPCC study team 
to ensure that all reports, study materials, and meeting arrangement notices are sent to the proper 
individuals in a timely fashion. She will work closely with the Project Director in the Chairman’s office to 
ensure that the study runs smoothly and will be in contact with both the National Study Coordinator and 
the Local Research Coordinators at the participating centers at least monthly to discuss any problems 
that they may be having, including those with the CSPCC. She will also work with the local VA R&D 
Offices at the participating centers to obtain R&D and IRB approvals at the beginning of the study and 
annually as well as the preparation of study budgets yearly during the ongoing phases of the study. 
The Statistical Programmer is responsible for the preparation of the tables and analyses for all of 
the routine study reports. These include Study Group, Executive Committee, Data Monitoring 
Committee, and the mid-study report to CSSEC. S/he also prepares the tables and reports for the final 
analyses. S/he works closely with the Biostatistician on these analyses.  
The Database Management System (DBMS) Programmer is the lead of the data management 
support group and works closely with the assigned computer assistant(s) to address the data 
management need for the assigned study. S/he is responsible for establishing, updating and maintaining 
the study’s database. In addition, s/he will write edit program based on an agreed upon edit plan that 
will thoroughly check the data for errors and missing information. S/he is also responsible for 
programming and maintaining the randomization system for the study. 
The Computer Assistant(s) are responsible for setting up the data definition table for the study, 
laying out the electronic case report forms in the form design software, and validating all incoming data. 
They are also responsible for training the study staff at each site on how to properly manage the data 
collection process and how to appropriately respond to data edits. The computer assistant(s) are also 
responsible for working with the sites to resolve the data queries generated based on the incomplete 
and/or inaccurate data submitted to the study database.   
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-2 

Randomization and Data Management: 
 
 
Randomization and Data management will be performed by the VA CSPCC Perry Point, MD. An 
Interactive Touchtone Telephone Randomization System (ITTRS) will be used to set up the 
randomization system. Clinical DataFax System, a data management software will be used for data 
management.  The CSPCC will have overall responsibility for the data at the end of the study. 
Randomization 
 
After a patient at any of the participating centers is consented, successfully screened and has 
provided baseline information, s/he will be assigned to a harvester. Once a harvester is assigned and 
available for the harvesting of the required vein, the patient will be randomized. The research 
coordinator will place a call to the ITTRS (a dedicated 1-800 phone number will be provided) to 
randomize the patient in one of the two harvesting techniques – endoscopic and open vein harvesting 
techniques. Once the required information is entered in the system, the system will return the 
assignment for the patient. This study will use a “permuted block” randomization scheme where 
random block sizes of two and four will be used. The research coordinator will need the following 
information in order to complete a successful randomization call: 
a. Study number and study password (will be provided by CSPCC)) 
b. 3-digit site number and password (will be provided by CSPCC) 
c. The subject’s ID Number & ALPHA Code  
d. The subject’s signed Informed Consent Form 
e. Form 01, Screening and Randomization 
f. Laminated Randomization Cheat Sheet 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-3 

a. Data Capture during visits and/or telephone contacts 
 
The system for data capturing will be designed by visits where a group of required CRFs will be 
assigned to each “visit” according to the “Schedule of Assessments” table.  
FORM 
SCREEN 
BASELINE 
(pre op) 
INTRA 
OP 
POST 
OP 
DC-
30 
DAY 
6 
WK 
3 
MO 
6 
MO 
9 
MO 
12 
Mo 
… 
45 
MO 
49 
MO 
AS 
NEEDED 
00 –Screening Log 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
01 – Screening and Randomization 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
02 – Baseline  Information 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
03 – Seattle Angina Questionnaire 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
04 – VR-12 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
 
05 – Intraoperative Data Collection 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
06 – Post Operative Assessments 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
07 – Discharge Assessments 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
08 – Leg Incision Pain Questionnaire 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
09 – Leg Incision Pain 6 Week 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
10 – Leg Incision Assessment 
 
 
 
 
X 
X 
 
 
 
 
 
 
 
 
11 – Mace Event (6 Week) 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
12 – Phone Call Follow-up 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
13 – MACE Event Form 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
14 - Termination 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
15 - SAE 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
16 – SAE Follow-up 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
17 – Harvester Experience 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
18 – Protocol Noncompliance 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
19 – Confirmation of  MI by Local Site 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
20 – Confirmation of MI by Clinical Events 
Committee 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
21 – Cause of Death by Clinical Events 
Committee 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
86 - Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The draft versions of the CRFs can be found in Appendix E. The paper CRFs will be mailed to the 
sites. The research personnel will be filling up these CRFs during CABG, the 6-week clinic visit, and the 3-
month phone calls. The completed CRFs will then be scanned in pdf and sent to Perry Point CSPCC via 
secure electronic server or posted on an ftp server. At CSPCC, the data management section staff will 
validate the CRFs once received by the DataFax system and will generate QC reports with listing of data 
discrepancies and other irregularities at regular intervals. These QC reports will be sent to the respective 
sites for clarifications and the site personnel will then submit “Refaxes” with clarification which will be 
validated and committed to the study master database (A “Refax” is a page of a CRF with corrections 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-4 

which is sent back to the CSPCC by agreed upon mode of CRF transmission). The final responsibility for 
the completeness and accuracy of all study data collected at a participating site resides with the SI who 
will review all data before submission.  The study database will be continuously updated with new data 
and changes to previously submitted data.  To notify the participating sites about missing or late forms, 
reports with pertinent information will be generated at a regular interval and will be posted on site-
accessible sub-SharePoint site.   
 
In addition, a summary report of all data submitted and problems identified will be generated 
for each participating site.  This report will provide each site with a summary of their progress.  The 
National Study Coordinator in the Chairman’s Office will also be reviewing each site’s progress to ensure 
that there are no unforeseen problems with the forms or with a particular patient. 
 
Another mechanism used to monitor the data and the progress of the study will be the 
preparation of periodic reports for various groups who are responsible for overseeing the conduct of the 
study.  These groups include the Study Group, the Executive Committee, the Data Monitoring 
Committee, and the CSPCC Human Rights Committee, if applicable.  These groups will receive study 
progress reports prior to their annual meetings and at least once in between their annual meetings.  
Thus, on average, these groups will receive a report every six months.  The contents of these reports are 
discussed in the remainder of this appendix. 
 
Monitoring Of Study By Study Group and Executive Committee: 
 
 
The Study Group (all of the Sis, harvesters and research coordinators) and Executive Committee 
will meet six to nine months after patient recruitment begins and at annual intervals thereafter until the 
end of the study.  Three weeks prior to these meetings and at six-month intervals between the 
meetings, these groups will be provided a report that will allow them to assess study progress.  Since 
both groups are composed of study team members, no outcome data with harvesting group assignment 
(data that would potentially break the study blind) will be provided in these reports.  These reports will 
contain information on: 
 
a. Screening, Enrollment and Retention 
 
 
The study team at each site will identify patients who might be candidates for the study.   After 
the study has been explained to the patient and the patient signs the informed consent form, the 
screening process will be initiated.  The research coordinator will complete the screening forms using 
the paper CRFs provided by the CSPCC Perry Point.  If the patient meets all eligibility criteria, the 
baseline forms will be completed.  The patient can then be randomized by completing the 
randomization form and placing a call to the ITTRS system (as described before) which will return the 
patient’s harvesting group assignment – EVH or OVH.   
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-5 

The progress of patient accrual will be presented to the monitoring groups in three formats: 
 
1. The study progress will be presented by site and for each site the following information will 
be provided: 
• 
actual number of patients entered into the study 
• 
expected number of patients to be entered at the time of the report, and  
• 
the percent of expected that were entered  
 
This format, as demonstrated in Table 1, will allow the Executive Committee to 
determine which sites are not recruiting as expected and the SIs to see how their site is 
doing in comparison with the others.   
2. The study progress will be presented by the number of patients entered into the study by 
month (Table 2).  These data will be organized by site.  The data will indicate if recruitment 
is improving or worsening over time at the various sites.  Sites whose intake is worsening 
can be detected and the SIs can be contacted to identify the reason for the recruitment 
deficit.  
3. Recruitment data will be plotted over time as shown in Figure 1.  The graph will be 
overlayed with the number of expected to be enrolled at the same time period.   
 
TABLE 1:  Number of Patients Entered and Number Expected 
Site 
Number 
Enrolled 
Number 
Expected 
Percent of 
Expected 
1 
2 
. 
. 
. 
16 
 
 
 
TOTAL 
 
 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-6 

TABLE 2:  Patient recruitment by month 
Month 
Site 1 
Site 2 
... 
Site 16 
01/13 
02/13 
. 
. 
. 
 
 
 
 
 
TOTAL  
 
 
 
 
 
 
 
Figure 1:  Observed Versus Expected Patient Recruitment  
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-7 

 
The number of patients screened, rejected and enrolled in the study will be presented in Table 3.  The 
reasons for the exclusion of screened patients will be presented in Table 4. 
TABLE 3:  Cumulative Screening Summary:  All Patients by Site 
Site 
Screened 
Rejected 
Enrolled 
% Rejected 
1 
2 
. 
. 
16 
 
 
 
 
TOTAL  
 
 
 
 
TABLE 4:  Summary of Ineligibility:  Reasons for Exclusion,  
Total and By Site 
TOTAL NUMBER SCREENED = ____________ 
Reason 
No. Excluded 
% of Screened 
1.  Combined valve procedure planned 
 
 
2.  Moderate or severe valve disease 
 
 
3.    Hemodynamically unstable or in cardiogenic 
shock. 
 
 
4.   Enrolled in a different therapeutic study (w/o 
special exception approved) 
 
 
. 
 
 
. 
 
 
. 
 
 
8.  Inability to provide informed consent 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-8 

 
b. Background Characteristics at Entry 
 
 
Background characteristics of the screened/enrolled study patients are collected on the 
Screening Record Form.  Tables summarizing the important background characteristics by site will be 
prepared and submitted to the Study Group to provide an idea of the population being studied and 
based on this information, comparisons of the patient characteristics among the sites will be possible.  
This information will be presented as means and medians for continuous variables (e.g., age) and as 
frequency tables for discrete variables (e.g., Gender).  Table 5 shows how this data will be presented.  
Analysis of variance and chi-square techniques will be used to identify any statistically significant 
differences that may exist between the sites. 
Table 5:  Demographic Variables by Center for CSP#588 
Variables 
 
Participating Centers 
1 
2 
… 
15 
16 
Total 
Age (Mean(SD)) 
 
 
 
 
 
 
Gender (N (%)) 
  Male 
 
 
 
 
 
 
  Female 
 
 
 
 
 
 
Race (N (%)) 
  American Indian/Alaskan 
 
 
 
 
 
 
  Asian/Pacific 
 
 
 
 
 
 
  Black  
 
 
 
 
 
 
  White 
 
 
 
 
 
 
  Other 
 
 
 
 
 
 
  Marital Status (N (%)) 
 Married/Remarried 
 
 
 
 
 
 
 Divorced 
 
 
 
 
 
 
 Separated 
 
 
 
 
 
 
 Widowed 
 
 
 
 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-9 

 Never Married 
 
 
 
 
 
 
 Education (N (%)) 
 Graduate/Professional 
 
 
 
 
 
 
 Std. College/Univ. degree 
 
 
 
 
 
 
 Partial College training 
 
 
 
 
 
 
 High School 
 
 
 
 
 
 
 <High School 
 
 
 
 
 
 
 
c. Data Quality and Protocol Adherence 
 
 
The final type of information that will be provided to the Study Group is data that will allow the 
group to assess the quality of the data being submitted and how well the sites, in general, are adhering 
to the protocol.  These data will also be presented by site, so sites performing substantially below 
average can be identified and remedial action can be taken to improve performance. 
 
One piece of information that will be routinely provided is the number of forms that are missing 
according to the patient’s assessment schedule.  Table 6 indicates how this information will be 
displayed. 
 
TABLE 6:  Number of Missing Forms  
# of Patients 
Site 
1 
2 
... 
16 
Total 
Form 01 
Form 02 
. 
. 
. 
Form 21 
N 
N 
 
 
 
N 
% 
% 
 
 
 
% 
 
 
 
 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-10 

Study Monitoring By Data Monitoring Committee: 
 
 
An independent oversight committee called the Data Monitoring Committee (DMC) will monitor 
study progress.  This committee meets on the same basic schedule as the Study Group and Executive 
Committee, i.e., at 6 to 9 months after the start of patient recruitment and yearly thereafter.  Initially, 
the DMC will meet once prior to the study start-up to acquaint themselves with the study and to 
establish monitoring guidelines.  This committee does not usually meet during the last six months of a 
study.   
 
 
The main responsibility for the DMC members is to make a recommendation to the Director of 
the Cooperative Studies Program on whether the study should continue or not based on the reviews of 
the progress reports submitted to them.  The study could be recommended for termination due to poor 
recruitment, difference so large that it would be possible to reach a final decision about the main 
question of the study, difference so small that continuation would be irresponsible, and due to safety 
concerns of the procedures that are being investigated.  The DMC also reviews the participating sites’ 
performance in terms of recruitment, adherence to the protocol etc., and makes recommendations on 
them.  Their final responsibility is to review all proposed protocol changes and suggested sub-protocols 
and to make recommendations in regards to their acceptability. 
 
 
In order for the DMC to carry out its responsibilities, the CSPCC Study Team will provide the 
committee with a report approximately three weeks prior to their meetings.  The report will consist of 
the tables described previously for the Study Group and Executive Committee reports as well as those 
presenting outcome analyses.  It is the responsibility of the CSPCC Study Team to provide the DMC with 
whatever information the Board feels that it needs to successfully monitor the study.  Thus, additional 
tables will be added as required by the DMC.  In addition to the reports for the yearly meetings, the 
DMC will also be provided with reports between meetings at 6-month intervals. 
 
 
In order for the DMC to make its recommendation for continuation of the study, it will be 
necessary for them to see the analyses for the primary outcome measure every time that the report is 
run and it is possible to calculate the primary outcome measure. Periodic monitoring of interim results 
can significantly affect the probability of making an incorrect decision.  A number of formal techniques 
have been developed for interpreting interim results. At the organizational meeting, the DMC will select 
the technique that it wants to use to monitor the study. Suggested techniques are the Haybittle-Peto 
and Lan-DeMets group sequential boundaries. For the Haybittle-Peto method, a constant z-statistic is 
used as the monitoring boundary. The Lan-DeMets procedure produces decision boundaries that are  
quite conservative over the first several looks and then gradually converges to the nominal alpha levels 
as the final look is approached.  Figure 2 gives an example of the Lan-DeMets boundaries for six looks at 
an alpha level of 0.05. 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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Figure 2: Lan-Demets Decision Boundary 
 
 
 
The patient characteristics would be presented by site and by harvesting technique group for 
the DMC.  Significant imbalances of these patient characteristics between the harvesting technique 
groups may indicate a need to use these characteristics as covariates during the analysis of the outcome 
measures.  Formal testing of the differences between groups will be done at the study’s conclusion 
using appropriate statistical tests - analysis of variance technique will be used to test characteristics that 
are continuous in nature, while chi-square technique will be used for the test characteristics that are 
discrete in nature.   
 
 
As with any clinical trial, the safety of the patient will be of utmost concern.  Safety will be 
monitored closely during the course of the study. The DMC Report will include data on incidence of 
adverse events by treatment group.  It will also include data on early terminations and treatment 
dropouts. The adverse event data will also be reported in the primary study manuscript.  Data will be 
collected on adverse events throughout the study starting immediately after the patient signs the 
informed consent form.   
 
Outcome Measures: 
 
 
The DMC reports and the final statistical report will include the statistical analyses of the 
primary and the secondary outcome measures for the study. The following paragraphs describe the 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-12 

outcome measures, the statistical techniques for the analyses and the table shells in which the results of 
the analyses will be presented in the reports.  
 
Primary Outcome Measure: 
 
 
Time-to-MACE event: MACE, the composite endpoint that includes Death (all cause), 
Myocardial Infarction (MI) and Revascularization for myocardial ischemia, will be the primary outcome 
measure after randomization and the index CABG. Each randomized subject (either in Endoscopic or in 
Open 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 an MI or a revascularization procedure during 
the follow-up period. Total follow-up period will be 6.5 years of which the first 4.5 years will be active 
follow-up (using in-clinic visit or by telephone) period and will be carried out by the site personnel. The 
remaining 2 years will be passive follow-up which will be carried out centrally by the chair’s office staff 
using the VA patient database. A minimum of 1 year of active follow-up will be used for subjects who 
will be enrolled almost at the tail end of the 3-year projected enrollment period of the study. The 
subjects who will either be lost to follow-up or will not experience an ‘EVENT’ before the end of the 
follow-up period will be considered as right censored.  
The primary analysis of such time-to-Mace event data will include the events only from the 
active follow-up period (which is 4.5 years). The secondary analysis will include events from the entire 
6.5 years of follow-up period.  
Survival analysis techniques will be used to analyze the time-to-MACE event data for both 
primary and secondary analyses.  
Kaplan-Meier analysis, a nonparametric method, will be used to estimate the survival (not 
experiencing MACE) over time in the two harvesting groups and a log-rank statistic will be used to test 
the equality of the survival function estimates in the two groups (the null hypothesis).   
Kaplan-Meier curves for all other predictors, e.g., age, gender etc., will also be plotted to 
provide insight into the shape of survival function for each group. These curves will also provide 
information about the proportionality among the groups (i.e., whether the curves are parallel or not). 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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A typical Kaplan-Meier curve showing survival probabilities in two treatment groups is shown in 
Figure 3. 
A test of equality across strata will also be performed to decide which predictor variables to 
include in the final model. For categorical variables log-rank tests, a non-parametric test, will be used 
and for continuous variables univariate Cox proportional hazard regression, a semi-parametric model, 
will be used. The results from the log-rank tests and univariate Cox proportional hazard regressions will 
be presented in the formats as shown in Tables 7 and 8. 
 
 
 
Figure 3: Typical Kaplan-Meier curve comparing two treatment groups 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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Table 7: Test of Equality over Strata 
Variable 
Test (Log-
Rank/MLE) 
Chi-Square 
Df 
Pr > Chi-Square 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
Cox’s Proportional Hazards models will be used to investigate the effect of harvesting technique on the 
time until MACE adjusted for other potential influential variables, such as, age, gender, harvester’s 
experience etc.  The predictors that are identified in the previous step will be included in the model.  
The results from the modeling will be presented in the format as shown in Table 8.  
 
Table 8: Cox Proportional Hazards Model to evaluate effect of EVH/OVH on time-to-MACE adjusted 
for predictor variables 
 
Variable 
Df 
Parameter 
Estimate 
Standard Error 
Chi-Square 
Pr > Chi-Square 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Secondary Outcome Measures: 
 
1. One-year MACE:  
Patients who will suffer any one of these three outcomes within the first year after 
index CABG will be counted towards calculating the proportions of patients with MACE 
(yes/no) in each harvesting technique group – patients with endoscopic vein grafting or 
patients with open vein grafting. Only the first event will be considered as a MACE 
event. These two proportions will be compared using a chi-square test. MACE data at 
one-year post surgery will be presented as shown in Table 9.  Tables 10, 11 and 12 
provide the format for the components of MACE – for example, death (all cause), MI, 
and repeat revascularization.  
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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Table 9: MACE distributions in harvesting technique groups at one-year post surgery 
 
            Harvesting 
MACE 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
Table 10: Death (all cause) distributions in harvesting technique groups 
 
            Harvesting 
Death (all Cause) 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
Table 11: MI distributions in harvesting technique groups 
 
            Harvesting 
MI 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-16 

Table 12: Revascularization distributions in harvesting technique groups 
 
            Harvesting 
Revascularization 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
2. Three-year MACE:  
Patients who will suffer any one of these three outcomes within the first three years 
after index CABG will be counted towards calculating the proportions of patients with 
MACE (yes/no) in each harvesting technique group – patients with endoscopic vein 
grafting or patients with open vein grafting. Only the first event will be considered as a 
MACE event. These two proportions will be compared using a chi-square test. MACE 
data at three-year post surgery will be presented as shown in Table 13.  Tables 14, 15 
and 16 provide the format for the components of MACE – for example, death (all cause), 
MI, and repeat revascularization.  
 
Table 13: MACE distributions in harvesting technique groups at two-year post surgery 
 
            Harvesting 
MACE 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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Table 14: Death (all cause) distributions in harvesting technique groups 
 
            Harvesting 
Death (all Cause) 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
Table 15: MI distributions in harvesting technique groups 
 
            Harvesting 
MI 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
Table 16: Revascularization distributions in harvesting technique groups 
 
            Harvesting 
Revascularization 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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3. Post-operative Leg Wound Healing Complications: Each patient in either harvesting 
technique group – EVH or OVH – will be examined for healing complications for their leg 
wounds from harvesting at discharge and at 6 weeks post-surgery. Post-operative leg 
wound healing complication status (yes/no) will be recorded at the discharge and also at 
6 weeks post-surgery. Proportion of patients with leg wound healing complications will 
be computed for each treatment group and these proportions at each time point will be 
compared using chi-square tests. The impact of confounding variables, such as, BMI, 
diabetes status, smoking status, and harvester experience  on the post-operative leg 
wound healing complications will be analyzed using a logistic regression. The results 
from the chi-square analysis will be presented with counts of ‘yes’ and ‘no’ in regards to 
leg wound healing complications in the two harvesting techniques as shown in Table 17.   
 
Table 17: Leg Wound Healing Complications distributions in harvesting technique groups 
 
            Harvesting 
Leg Wound 
Healing 
Complications 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
Table 18 provides the format in which the logistic regression analysis results for the leg 
wound healings complications will be presented. Each of the covariates in the model will 
be presented with individual odds ratio and 95% Confidence Interval.  
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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Table 18: Logistic Regression Analysis of Leg Wound Healing Complications Data at 6-week Post 
Surgery 
 
 
Odds Ratio 
 
 
95% Confidence Interval 
 
LL 
UL 
Harvesting 
Technique 
 
 
 
 
 
 
BMI 
 
 
 
 
 
Harvester 
Experience 
 
 
 
 
 
Age of patient 
 
 
 
Diabetes Status 
 
 
 
Smoking Status 
 
 
 
 
4. Severity of Incisional Leg Pain: Severe leg pain, due to incisions made during vein 
grafting, data will be collected at discharge and at six-week post CABG. Proportion of 
patients with severe pain (pain score 3 and above = yes) at each time point will be 
compared using chi-square statistics.  
The results from the chi-square analysis will be presented with counts of ‘yes’ and ‘no’ in 
regards to severity of incisional leg pain in the two harvesting techniques as shown in 
Table 19.   
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
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Table 19: Severity of Incisional Leg Pain distributions in harvesting technique groups 
 
            Harvesting 
Severity of Leg 
Pain 
OVH 
EVH 
 
Total 
 
No 
 
 
 
Yes 
 
 
 
Total 
 
 
 
ChiSq = 
p-value = 
 
5. Quality of Life: QoL scores, from VR-12 and Seattle Angina Questionnaire, will be 
computed at baseline, six-weeks, and 12 months post-surgery for the patients in both 
harvesting technique groups (EVH and OVH). Patients in the two groups will be 
categorized as “improved”, “no change” and “worse” based on their baseline scores. 
The proportions of patients in these three categories will be compared between the two 
groups using chi-square statistics. The actual scores from these measures will also be 
used to compare patients in the two harvesting technique groups using analyses of 
covariance techniques, where the baseline (pre-surgery) scores will be used as a 
covariate. The results from the chi-square analysis will be presented with counts of ‘yes’ 
and ‘no’ in regards to QoL scores categorized as “improved”, “no change” and “worse” 
in the two harvesting techniques as shown in Table 20.  Table 21 provides the format in 
which the results from ANCOVA analysis will be presented. 
 
 
Table 20: QoL/SAQ score distributions in harvesting technique groups 
 
            Harvesting 
QoL score 
OVH 
EVH 
 
Total 
 
Improved 
 
 
 
No Change 
 
 
 
Worse 
 
 
 
ChiSq = 
p-value = 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-21 

Table 21:  QoL/SAQ Scores by Harvesting Technique 
 
 
Treatment Group 
QoL Score 
N 
Mean 
. 
Standard Error 
OVH 
 
 
 
EVH 
 
 
 
Covariate 
Estimate 
Std. Error 
t-statistics 
p-values 
Harvesting Technique 
 
 
 
 
Baseline QoL Score 
 
 
 
 
Source 
Df 
F Statistics 
p-value 
Harvesting Technique 
 
 
 
Baseline QoL score 
 
 
 
 
 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
 
D-22 

Form 01 – Screening Record  
 
SITE NO. 
        SUBJECT ID                              ALPHA CODE                         DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
FORM 01 - SCREENING RECORD 
 
*Complete this form for all subjects undergoing a CABG procedure at your site and submit to 
the Perry Point Cooperative Studies Program within 48 hours of CABG procedure. 
 
 
INCLUSION CRITERIA 
 
                                    No      Yes      
1. Age 18 years or older?    ....................................................................................................... 
2. Elective or Urgent CABG-only (refer to protocol definition)? ............................................... 
3. Median sternotomy approach?  ...........................................................................................  
4. At least one coronary bypass planned using saphenous vein graft for conduit? ................. 
5. Experienced EVH/OVH harvester and participating surgeon available for procedure? ....... 
Answers to questions 1-5 must all be ‘YES’ for the subject to be eligible for enrollment 
 
EXCLUSION CRITERIA 
 
                                    No      Yes      
6. Combined valve procedure planned?    ................................................................................ 
7. Moderate or severe valve disease (see definition of moderate/severe valve disease)?  ..... 
8. Hemodynamically unstable or in cardiogenic shock?  ..........................................................    
9. Enrolled in another therapeutic or interventional study?  ................................................... 
(without special approval obtained for enrollment) 
10. Off-pump CABG procedure planned?  .................................................................................. 
11. Limited life expectancy less than 1 year? ............................................................................. 
12. History of lower extremities venous stripping or ligation?  .................................................. 
13. Inability to provide informed consent?  ................................................................................ 
Answers to questions 6-13 must all be ‘NO’ for the subject to be eligible for enrollment  
 
 
 
CSP#588 - REGROUP, Screening Record, Version 1.2 – October 1, 2013                         Form 01, Page 1 of 3 

Form 01 – Screening Record  
 
SITE NO. 
        SUBJECT ID                              ALPHA CODE           
 
 
 
 
 
 
 
ENROLLMENT                                                                                                                                                  No      Yes      
14. Is the subject eligible to be enrolled into the REGROUP study?  .......................................... 
If the answer to question 14 is NO, then STOP, SIGN form - this form is now complete. 
 
15. If the subject is eligible but not enrolled, mark (x) in the one box that best describes the reason: 
Subject refused to sign Informed Consent 
Eligibility status changed (e.g., died, treatment plan changed, etc.) 
Site surgeon concerned about resources needed for on-site follow-up (cost, time, etc) 
No reliable method of follow-up contact with the subject (e.g., no phone, etc.) 
Primary reason subject preferred non-enrollment  
 
  Subject prefers open vein harvest 
 
  Subject prefers endoscopic vein harvest 
 
 Reason other than vein harvest preference  
 
 
 specify:_______ 
 
 
 
 
 
 
Primary reason surgeon preferred non-enrollment 
 
  Surgeon prefers open vein harvest for subject 
 
  Surgeon prefers endoscopic vein harvest for subject 
 
  Reason other than vein harvest preference.  
 
 
 specify: 
_______ 
 
 
 
 
 
If the subject was not enrolled in the study, STOP, SIGN form - this form is now complete. 
RANDOMIZATION  - If the subject is eligible and willing to be randomized, call CSPCC at 410-642-1736 
 
 
 
 
 
 
                                                          
            No      Yes  
 
16.   Was the subject randomized into the study?  ..................................................................... 
If Q 16 is Yes then go to Q 18. If Q 16 is No then go to Q 17 and the form is complete when signed. 
 
CSP#588 - REGROUP, Screening Record, Version 1.2 – October 1, 2013                         Form 01, Page 2 of 3 

Form 01 – Screening Record  
 
SITE NO. 
        SUBJECT  ID                             ALPHA CODE           
 
 
 
 
 
 
 
17.   If the subject has signed the consent but was not randomized, mark (x) in the one box that best 
describes the reason: 
 
Eligibility status changed 
 
 
 
explain: 
____________________________ 
 
 
 
 
Subject changed mind after consent signed 
 
explain: 
____________________________ 
 
 
 
 
Surgeon changed mind after subject signed consent  
 
explain: 
___________________________ 
 
 
 
 
Other reason (specify):_____________________________________________________ 
 
 
18.   If the subject is randomized, complete the following information:                                         
 
a.   Date subject was randomized  ..................................  
                                                                                                                      Month            Day                 Year      
b. Time subject was randomized (Military Time)  ............................................  
                                                                                                                                        hour    :     min 
c.    Assigned harvester ID Number  ................................................................................... 
d.    Assigned surgeon ID Number  ..................................................................................... 
e. Envelope Number     ...........................................................................                     - 
 
                                                                                                                                       EVH        OVH 
f. To what treatment was subject randomized?  ....................................................  
 
S.I. or Participating Surgeon Signature    
 
________ 
 
 
 
Print Name:   
 
 
 
 
 
 
 
 
 
 
Print name of the person completing this form if other than the site coordinator: ___________________ 
 
CSP#588 - REGROUP, Screening Record, Version 1.2 – October 1, 2013                         Form 01, Page 3 of 3 

Form 02 – Baseline Information  
SITE NO. 
        SUBJECT ID                             ALPHA CODE                         DATE OF ASSESSMENT 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
                        
 
FORM 02 – BASELINE INFORMATION 
COLLECT DATA FROM THE EXISTING MEDICAL RECORD FOR RANDOMIZED SUBJECTS. 
IDENTIFICATION DATA 
 
1. DATE OF BIRTH:  
                                         month            day                    year 
                                                                                                 
DEMOGRAPHIC DATA 
2. GENDER: 
 
Male 
 
 Female 
3. RACE:           American Indian or Alaskan Native 
 
 
 
Asian or Pacific Islander 
 
 
 
Black, not of Hispanic origin 
                          Hispanic 
 
 
 
White, not of Hispanic origin 
 
 
 
Other, specify: _________________________  
 
 
 
4. MARITAL STATUS: 
Married/remarried 
 
 
 
Divorced  
 
 
 
Separated  
 
 
 
Widowed  
 
 
 
Never married  
 
5. EDUCATION: 
 Completed Graduate/professional training 
 
 
 
Standard college/university graduate 
 
 
 
Partial college training 
 
 
 
High school graduate/GED 
 
 
 
< High school   
                                                                                                           
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 1 of 11 
 
 

Form 02 – Baseline Information  
 
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
MILITARY SERVICE HISTORY: 
 
6. Served in the military? 
 
No           
Yes 
 
a. If Yes, when did the patient serve: (mark ‘x’ all that apply) 
 World War I 
 
 
Balkans conflict  
 
 
 
 
 
World War II 
 
 
Afghanistan conflict  
 
 
 
Korean conflict   
 
Iraq conflict  
 
 
 
Vietnam conflict  
 
Other war/conflict, specify: ____________________ 
 
 
 
 
Gulf War 
 
 
Peace time  
 
b. If Yes, served outside the U.S.: 
 
No           
Yes 
 
c. If Yes, specify branch: 
 
 
 
 
 
Army 
 
 
 
Coast Guard   
 
 
 
Air Force  
 
 
National Guard (active duty)  
 
 
 
Navy 
 
  
 
Merchant Marine 
 
 
 
 
Marines 
 
 
  
 
PRE-OPERATIVE CLINICAL DATA, CO-MORBIDITIES  
 
7. Diabetes:  
 
 
No           
Yes 
 
a. If Yes, how controlled? 
None 
 
Diet         
Oral Hypoglycemic 
 
Insulin 
8. Hypertension: 
 
 
No           
Yes 
9. Hyperlipidemia:  
 
 
No           
Yes 
10. Depression : 
 
 
No           
Yes 
11. Chronic Renal Disease: 
 
No           
Yes 
 
a. If Yes, requires dialysis? 
No 
 
Yes 
12. Chronic Liver Disease:  
 
No           
Yes 
13. Peripheral Vascular Disease: 
No           
Yes 
14. Cerebral Vascular Disease: 
No           
Yes 
 
a. If Yes, CVA?      
 
No           
Yes 
b. If Yes, specify interval:  
< 2weeks           > 2weeks 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 2 of 11 
 
 

Form 02 – Baseline Information  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
15. Chronic Lung Disease: 
 
No           
Yes 
 
a. If Yes, FEV1:     
 
 
      % predicted  
 
16. Immunosuppressive Therapy:  
No           
Yes 
 
17. Tobacco use > 100 cigarettes/lifetime: 
No          Yes 
       a. If Yes, last use prior to surgery: 
 
 
< 7 days 
 
 
> 3 months but < 1 year 
 
 
> 7 days but < 3 months  
> 1 year 
 
18. Alcohol use > 1 ounce/day:  
No           
Yes 
a. If Yes, last use prior to surgery: 
 
 
< 7 days 
 
 
> 3 months but < 1 year 
 
 
> 7 days but < 3 months  
> 1 year 
 
 
 
 
 
19. Other major comorbidity:   
No           
Yes 
   
a. If Yes, specify: _________________________________________ 
20. Residential Status (resides with): 
 
 
Spouse  
 
 
Assisted Facility 
 
 
Family/other 
 
 
Alone 
21. Functional Status: (ability to complete activities of daily living) 
 
 
Independent 
 
 
Needs Assistance 
 
Dependent 
 
CARDIAC STATUS 
 
22. Previous CABG Procedure:  
No           
Yes 
If Yes, Date:   
 
 
 
 
 
 
 
 
                       month            day                    year 
 
23. Previous Valve Procedure:  
No           
Yes 
If Yes, Date:   
                                                                                                           
        month            day                    year 
 
 
 
 
 
 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 3 of 11 
 
 

Form 02 – Baseline Information  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
 
 
 
 
 
 
 
             
24. Previous PCI Procedure:   
No           
Yes 
If Yes, Date:   
 
 
 
 
 
 
 
 
                       month            day                    year 
a. If Yes, specify interval:              <6 hours 
>6 hours 
 
25. Myocardial Infarction: 
 
No           
Yes 
If Yes, Date:   
 
a. If Yes, specify interval: 
 
 
 
                       month            day                    year 
< 6 hours 
 
 
>7 days but < 21 days 
 
 
 
>6 hours but < 24 hours  
>21 days 
 
 
 
 >1 day but <7 days 
 
26.  Peak Cardiac Biomarkers (if available);          No            Yes     If Yes, Date: 
                                                                                                                                         month           day                    year 
If yes, you must complete A, B, OR C below 
  
A. Peak Cardiac Troponin I 
 
1.  Peak Cardiac Troponin I (ng/mL):                        .                 
 
 
 
 
 
2.   Reference Range (ng/mL):             .                  to            . 
B. Peak Cardiac Troponin T 
1. 
Peak Cardiac Troponin T (ng/mL):                      .          
   
2. 
Reference Range (ng/mL):             .                   to            . 
C.  Peak CPK/MB Panel 
1. 
Peak Total CPK (U/L):  
                                                          
 
 
 
2. 
Total CPK Reference Range (U/L):                         to  
3.    Peak CK-MB (ng/mL):                                .                                               
 
 
 
 
4.  
CK-MB Reference Range (ng/mL):                  to           . 
5.   Peak CK-MB Index (%):                             .                         
6. 
CK-MB Index Reference Range (%):            .           to            . 
 
 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 4 of 11 
 
 

Form 02 – Baseline Information  
        SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
 
27. Heart Rate by ECG: 
<100 
       >100  
 
Date:   
 
 
 
 
 
 
 
 
               month            day                    year 
 
28. Arrhythmia by ECG: 
No           
Yes 
     If Yes, Date:   
 
a. If Yes, specify: 
 
 
 
 
               month            day                    year 
 
 
Atrial fibrillation 
 
Pacemaker 
 
 
 
Atrial Flutter 
 
 
Other, specify: _________________ 
 
29. Cardiomegaly by CXR:  
No           
Yes 
     If Yes, Date:   
 
 
 
 
 
 
 
 
               month            day                    year 
30. Ejection fraction by ECHO:  
 
     % 
 
  Date: 
month            day                    year 
 
31. LV aneurysm by ECHO:  
No           
Yes 
     If Yes, Date:   
 
 
 
 
 
 
 
 
               month            day                    year 
32. Presentation on Admission: (mark only one) 
 
 
No symptoms or angina  
Unstable angina 
 
 
 
Symptoms, non-ischemic 
Non-ST elevation MI 
 
 
 
Stable angina 
 
 
ST elevation MI 
a. If experiencing angina classify by CCSS:          Class I              Class II 
Class III  
Class IV  
 
33. Congestive Heart Failure:  
No 
 
Yes 
 
a. If Yes, classify by NYHA:  
Class I  
Class II  
Class III  
Class IV 
 
 
34. Presence of Pulmonary Rales:  
No 
 
Yes 
     If Yes, Date:   
                                                                                      
 
               
  month            day                    year 
 
35. Infectious Endocarditis:  
 
No 
 
Yes 
     If Yes, Date:   
 
 
 
 
 
 
 
 
 
 
   month            day                    year 
a. If Yes, specify type: 
 
Treated 
Active  
 
 
 
36. Cardiogenic Shock:  
 
No 
 
Yes 
     If Yes, Date:   
 
 
 
 
 
 
 
 
 
 
   month            day                    year 
 
 
 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 5 of 11 
 
 

Form 02 – Baseline Information  
 
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
37. Resuscitation:  
 
 
No 
 
Yes 
     If Yes, Date:   
 
 
 
 
 
 
 
 
 
 
   month            day                    year 
38. Inotropes: 
 
 
No 
 
Yes 
 
39. Status of Index CABG Procedure: 
 
 
Elective  
 
 
Emergent * 
 
 
 
Urgent  
 
 
Emergent salvage * 
(*NOTE: ‘Emergent’ and ‘Emergent salvage’ are exclusion criteria.) 
 
 
 
 
 
 
 
                
VALVE DISEASE BY ECHO TYPE (Note: ‘Moderate’ and ‘Severe’ are exclusion criteria.) 
 
40. Aortic regurgitation (Insufficiency)  
              None  
   Trivial  
   Mild (1+) 
   Moderate (2-3+) 
   Severe (4+) 
 
41. Aortic stenosis 
              None  
   Trivial  
   Mild (1+) 
   Moderate (2-3+) 
   Severe (4+) 
                                                                                                           
42. Mitral regurgitation (Insufficiency)  
              None  
   Trivial  
   Mild (1+) 
   Moderate (2-3+) 
   Severe (4+) 
 
43. Mitral stenosis  
              None  
   Trivial  
   Mild (1+) 
   Moderate (2-3+) 
   Severe (4+) 
 
44. Tricuspid regurgitation (Insufficiency) 
              None  
   Trivial  
   Mild (1+) 
   Moderate (2-3+) 
   Severe (4+) 
                                                                                                                 
CORONARY STATUS 
 
45. Coronary angiography performed:  
               
 
 
 
         month            day                    year 
 
46. Dominant coronary system:  
       Right 
 
Left 
 
Co-dominant  
 
47. Left main > 50% stenosis:   
       No  
 
Yes 
 
48. Diseased territories: 
 
 
Single vessel disease 
 
Double vessel disease  
Triple vessel disease 
49. Syntax Score: 
           (www.syntaxscore.com) 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 6 of 11 
 
 

Form 02 – Baseline Information  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
 
CASS SITE CODES 
1 = Prox RCA 
6 = 1st RPL 
11 =LMCA 
16 = 2nd Diag 
21 = 2nd OM 
26 = 3rd LPL 
2 = Mid RCA 
7 = 2nd RPL 
12 = Prox LAD 
17 = 1st Septal 
22 = 3rd OM 
27 = LPDA 
3 = Dist RCA 
8 = 3rd RPL 
13 = Mid LAD 
18 = Prox Cx 
23 = Dist Cx 
28 = RAMUS 
4 = RPDA 
9 = Inferior Septal 
14 = Dist LAD 
19 = Mid Cx 
24 = 1st LPL 
29 = 3rd Diag 
5 = RPAV 
10 = Acute Marginal 
15 = 1st Diag 
20 = 1st OM 
25 = 2nd LPL 
30 = Unknown 
 
CORONARY MAP: 
  
54.  Intent to bypass    
 
 
 
a. 
 If yes, Type of conduit to be used 
 
 
 
 
 
     a. 
     b. 
     c. 
     d. 
     e. 
     f. 
50. CASS Site 
 
 
 
 
 
 
 
51. Stenosis % 
 
 
 
 
 
 
52. Vessel Diameter   
       (mm) 
 
         . 
 
         . 
 
         . 
 
         . 
 
         . 
 
         . 
53. PCI 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
       No 
 
       Yes 
 
 
a. 
       LIMA 
       RIMA 
       Radial Artery 
       Venous 
       Other 
______________ 
 
 
b. 
       LIMA 
       RIMA 
       Radial Artery 
       Venous 
       Other 
______________ 
 
 
c. 
       LIMA 
       RIMA 
       Radial Artery 
       Venous 
       Other 
______________ 
 
 
d. 
       LIMA 
       RIMA 
       Radial Artery 
       Venous 
       Other 
______________ 
 
 
e. 
       LIMA 
       RIMA 
       Radial Artery 
       Venous 
       Other 
______________ 
 
 
f. 
       LIMA 
       RIMA 
       Radial Artery 
       Venous 
       Other 
______________ 
 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 7 of 11 
 
 

Form 02 – Baseline Information  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
PHYSICAL ASSESSMENT  
                        
55. Height:                                   cm 
 
56. Weight:                             .           kg 
 
57. Body Surface Area (Mosteller Formula):                .                  m2 
 
58. Body Mass Index (NHLBI Calculator):                      .          kg/m2 
 
59. Ankle-Brachial Index (lower ABI) – RIGHT: (research procedure)                                  . 
 
60. Ankle-Brachial Index (lower ABI) – LEFT: (research procedure)                                     . 
 
 
CLINICAL LABORATORY DATA (If no results available, leave blank) 
 
61. HbA1c 
 
                 .   . 
%  
      
Date:   
 
 
 
 
 
 
 
 
month            day                    year 
 
62. Potassium                
  . 
mEq/L  
Date:  
    Serum           plasma  
 
 
 
month            day                    year 
 
63. Serum Creatinine  
  . 
mg/dL  
Date:  
month            day                    year 
 
64. Plasma Creatinine  
  . 
mg/dL  
Date:  
month            day                    year 
 
65. eGFR (IDMS) < 60?               No            Yes 
   
Date:  
month            day                    year 
 
66. C-Reactive Protein 
   . 
mg/dL  
Date:  
       (hs-CRP)  
 
 
 
 
 
month            day                    year 
 
67. White Blood Cell     
    .                  103/mm3 Date:  
       Count (WBC) 
 
 
 
 
 
month            day                    year 
 
68. Hematocrit (HCT)                   . 
% 
 
Date:  
month            day                    year 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 8 of 11 
 
 

Form 02 – Baseline Information  
 
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                          
               
 
69. Total Cholesterol   
  . 
mg/dL  
Date:  
      (fasting TC) 
 
 
 
 
 
month            day                    year 
 
70. High Density  
 
  . 
mg/dL  
Date:  
      Lipoproteins (fasting HDL)  
 
 
 
 month            day                    year 
 
71. Low Density  
 
  . 
mg/dL  
Date:  
      Lipoproteins (fasting LDL)  
 
 
 
 month            day                    year 
 
72. Triglycerides  
 
  . 
mg/dL  
Date:  
      (fasting TRG) 
 
 
 
 
 
 month            day                    year 
 
 
30 DAY MORTALITY SURGICAL RISK ASSESSMENT  
 
73.  VASQIP Patient Risk Calculation (Online Calculator):           .           % 
 
74. STS Risk of Mortality (Online STS Risk Calculator):                .                   % 
 
VENOUS CLINICAL SEVERITY SCORE 
 
75. Pain or other discomfort (i.e., aching, heaviness, fatigue, soreness, burning)  
 
 
 
 
0= None  
 
 
1= Mild – Occasional pain or discomfort that does not restrict regular daily activities 
 
 
2= Moderate – Daily pain or discomfort, interferes with, but does not prevent, regular daily activities  
 
 
3= Severe – Daily pain or discomfort that limits most regular daily activities 
 
 
 
  
 
76. Varicose Veins (>3mm in diameter, use standing position for assessment)  
 
 
 
 
0= None  
 
 
1= Mild – Few, scattered, varicosities that are confined to branch veins or clusters 
 
 
2= Moderate – Multiple varicosities that are confined to the calf or the thigh  
 
3= Severe – Multiple varicosities that involve both the calf and the thigh  
 
 
 
 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 9 of 11 
 
 

Form 02 – Baseline Information  
 
 
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
77. Venous Edema (exam may be supplemented by asking patient about edema) 
 
 
0= None  
 
 
1= Mild – Edema is limited to the foot and ankle 
 
 
2= Moderate – Edema extends above the ankle but below the knee  
 
3= Severe – Edema extends to the knee or above 
 
78. Skin Pigmentation (color changes of venous origin, not from other chronic diseases) 
 
 
 
0= None  
 
 
1= Mild – Pigmentation that is limited to the peri malleolar area 
 
 
2= Moderate – Diffuse pigmentation that involves the lower third of the calf  
 
3= Severe – Diffuse pigmentation that involves more than the lower third of the calf  
 
  
 
79. Inflammation (erythema, cellulitis, venous eczema, or dermatitis)  
 
 
 
 
0= None  
 
 
1= Mild – Inflammation that is limited to the peri malleolar area 
 
 
2= Moderate – Inflammation that involves the lower third of the calf  
 
 
3= Severe – Inflammation that involves more than the lower third of the calf 
 
 
  
 
80. Induration (refers to skin and subcutaneous changes)  
 
 
 
 
0= None  
 
 
1= Mild – Iduration that is limited to the peri malleolar area 
 
 
2= Moderate – Iduration that involves the lower third of the calf  
 
3= Severe – Induration that involves more than the lower third of the calf 
 
81. Active Ulcer Number (count the number of active leg ulcers) 
 
 
0= None (Skip questions 82-84, calculate total score and sign form) 
 
 
1= Mild – 1 ulcer 
 
 
2= Moderate – 2 ulcers  
 
3= Severe – >3 ulcers 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 10 of 11 
 
 

Form 02 – Baseline Information  
 
 
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
82. Active Ulcer Duration (if there is at least one active ulcer) 
 
 
1= Mild – Ulceration present <3 months 
 
 
2= Moderate – Ulceration present 3-12 months  
 
3= Severe – Ulceration present > 12 months  
 
 
83. Active Ulcer Size (if there is at least one active ulcer) 
 
 
1= Mild – Ulcer <2 cm in diameter 
 
 
2= Moderate – Ulcer 2-6 cm in diameter  
 
3= Severe – Ulcer >6 cm in diameter 
 
84. Compression Therapy (if there is at least one active ulcer) 
 
 
0= None  
 
 
1= Mild – Intermittent use 
 
 
2= Moderate – Wears stockings most days  
 
3= Severe – Full compliance: stockings  
 
85. TOTAL VENOUS CLINICAL SEVERITY SCORE (add totals for Questions 75-84) =  
 
 
 
 
 
 
 
 
 
S.I. Signature ________________________________________             Date ___________________ 
 
                 CSP#588 – REGROUP, Baseline Information, Version 1.2 – October 1, 2013   
 
 
 
       Form 02, Page 11 of 11 
 
 

Form 03 – Seattle Angina Questionnaire  
 
 
 
VISIT NO.            SITE NO.                 SUBJECT ID                       ALPHA CODE                         DATE OF ASSESSMENT 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
 
FORM 03 - THE SEATTLE ANGINA QUESTIONNAIRE 
 
 
1. 
The following is a list of activities that people often do during the week.  Although for 
some people with several medical problems it is difficult to determine what it is that limits 
them, please go over the activities listed below and indicate how much limitation you 
have had due to chest pain, chest tightness, or angina over the past 4 weeks.  Mark 
an X in one box on each line. 
 
 
  
 
 
ACTIVITIES 
 
Extremely 
Limited 
 
 
Quite a 
Bit 
Limited 
 
Moderately 
Limited 
 
Slightly 
Limited 
 
Not at 
all 
Limited 
 
Limited 
for other 
reasons 
or did not 
do the 
activity 
 
a.   Dressing yourself 
 
 
 
 
 
 
 
 
 
 
 
 
 
b.   Walking indoors on level          
      ground 
 
 
 
 
 
 
 
c.   Showering 
 
 
 
 
 
 
 
d.  Climbing a hill or a flight  
     of stairs without stopping 
 
 
 
 
 
 
 
e.   Gardening, vacuuming,  
     or carrying groceries 
 
 
 
 
 
 
 
f.   Walking more than a  
     block at a brisk pace 
 
 
 
 
 
 
 
g.  Running or jogging 
 
 
 
 
 
 
 
h. Lifting or moving heavy objects  
    (e.g. furniture, children) 
 
 
 
 
 
 
 
i. Participating in strenuous sports  
   (e.g. swimming, tennis) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 – REGROUP, Seattle Angina Questionnaire, Version 1.2 – October 1, 2013 
Form 03 Page 1 of 5 
 

Form 03 – Seattle Angina Questionnaire  
 
VISIT NO.          SITE NO.                     SUBJECT ID                          ALPHA CODE           
 
 
 
 
 
 
 
2. 
Compared with 4 weeks ago, how often do you have chest pain, chest tightness, or 
angina when doing your most strenuous activities? I have had chest pain, chest tightness, 
or angina  
Much more often  ........................................................   
Slightly more often  .....................................................  
About the same  ..........................................................  
Slightly less often  .......................................................  
Much less often  ..........................................................  
I have had no chest pain over the last 4 weeks  ........  
 
3. 
Over the past 4 weeks, on average, how many times have you had chest pain, chest 
tightness, or angina?  I have had chest pain, chest tightness, or angina  
 
4 or more times per day  .............................................   
1-3 times per day ........................................................  
3 or more times per week but not every day ...............  
1-2 times per week ......................................................  
Less than once a week ...............................................  
None over the past 4 weeks  ......................................  
 
4. 
Over the past 4 weeks, on average, how many times have you had to take nitroglycerin 
(nitroglycerin tablets or spray) for your chest pain, chest tightness, or angina? 
I have taken nitroglycerin 
 
 
 
 
 
4 or more times per day  .............................................   
1-3 times per day ........................................................  
3 or more times per week but not every day ...............  
1-2 times per week ......................................................  
Less than once a week ...............................................  
None over the past 4 weeks  ......................................  
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 – REGROUP, Seattle Angina Questionnaire, Version 1.2 – October 1, 2013 
Form 03 Page 2 of 5 
 

Form 03 – Seattle Angina Questionnaire  
 
VISIT NO.          SITE NO.                     SUBJECT ID                          ALPHA CODE           
 
 
 
 
 
 
 
 
5. 
How bothersome is it for you to take your pills for chest pain, chest tightness or angina as 
prescribed? 
Extremely bothersome ................................................   
Quite a bit bothersome ................................................  
Moderately bothersome ..............................................  
Slightly bothersome .....................................................  
Not bothersome at all ..................................................  
My doctor has not prescribed pills ..............................  
 
6. 
How satisfied are you that everything possible is being done to treat your chest pain, 
chest tightness, or angina? 
Not satisfied at all ........................................................   
Mostly dissatisfied .......................................................  
Somewhat satisfied .....................................................  
Mostly satisfied ............................................................  
Completely satisfied ....................................................  
 
7. 
How satisfied are you with the explanations your doctor has given you about your chest 
pain, chest tightness, or angina? 
Not satisfied at all ........................................................   
Mostly dissatisfied .......................................................  
Somewhat satisfied .....................................................  
Mostly satisfied ............................................................  
Completely satisfied ....................................................  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 – REGROUP, Seattle Angina Questionnaire, Version 1.2 – October 1, 2013 
Form 03 Page 3 of 5 
 

Form 03 – Seattle Angina Questionnaire  
 
 
VISIT NO.          SITE NO.                     SUBJECT ID                          ALPHA CODE           
 
 
 
 
 
 
 
 
 
 
 
8. 
Overall, how satisfied are you with the current treatment of your chest pain, chest 
tightness, or angina? 
Not satisfied at all ........................................................   
Mostly dissatisfied .......................................................  
Somewhat satisfied .....................................................  
Mostly satisfied ............................................................  
Completely satisfied ....................................................  
 
9. 
Over the past 4 weeks, how much has your chest pain, chest tightness, or angina limited 
your enjoyment of life? 
It has extremely limited my enjoyment of life ..............   
It has limited my enjoyment of life quite a bit ..............  
It has moderately limited my enjoyment of life ............  
It has slightly limited my enjoyment of life ...................  
It has not limited my enjoyment of life at all ................  
 
10. 
If you had to spend the rest of your life with your chest pain, chest tightness, or angina 
the way it is right now, how would you feel about this? 
Not satisfied at all ........................................................   
Mostly dissatisfied .......................................................  
Somewhat satisfied .....................................................  
Mostly satisfied ............................................................  
Completely satisfied ....................................................  
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 – REGROUP, Seattle Angina Questionnaire, Version 1.2 – October 1, 2013 
Form 03 Page 4 of 5 
 

Form 03 – Seattle Angina Questionnaire  
 
 
VISIT NO.          SITE NO.                     SUBJECT ID                          ALPHA CODE           
 
 
 
 
 
 
 
 
 
 
 
11. 
How often do you think or worry that you may have a heart attack or die suddenly? 
I can’t stop thinking or worrying about it .....................   
I often think or worry about it .......................................  
I occasionally think or worry about it ...........................  
I rarely think or worry about it ......................................  
I never think or worry about it ......................................  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 – REGROUP, Seattle Angina Questionnaire, Version 1.2 – October 1, 2013 
Form 03 Page 5 of 5 
 

Form 04 – Veterans Rand 12 Item Health Survey  
 
 
VISIT NO.            SITE NO.                 SUBJECT ID                       ALPHA CODE                         DATE OF ASSESSMENT 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
FORM 04 – THE VETERANS RAND 12 ITEM HEALTH SURVEY (VR 12) 
 
 
 1. 
In general, would you say your health is: 
 
  
Excellent 
Very good 
Good 
Fair 
Poor 
 
 
 
 
 
 
 
 
 
 
 
 2. 
The following questions are about activities you might do during a typical day.  Does 
your health now limit you in these activities?  If so, how much?   
 
 
 
 
Yes, 
Limited 
A Lot 
 
Yes, 
Limited 
A Little 
 
No, Not 
Limited 
At All 
 
a.  Moderate activities, such as moving a table, 
     pushing a vacuum cleaner, bowling, or playing golf? 
 
 
 
 
 
 
 
b.  Climbing several flights of stairs? 
 
 
 
 
 
 
 
 3. 
During the past 4 weeks, have you had any of the following problems with 
 your work or other regular daily activities as a result of your physical health? 
  
 
 
 
No, 
None 
 of the 
 Time 
 
Yes, 
 a Little 
of the 
Time 
 
Yes, 
Some 
of the 
Time 
 
Yes, 
Most 
of the 
Time 
 
Yes,  
All 
of the 
Time 
 
a.  Accomplished less than you would like. 
 
 
 
 
 
 
 
 
 
 
 
b.  Were limited in the kind of work or other activities. 
 
 
 
 
 
 
 
 
 
 
 
 
INSTRUCTIONS: This questionnaire asks for your views about your health.  This information will help keep 
track of how you feel and how well you are able to do your usual activities.  For each of the following 
questions, please mark an ‘X’ in the one box that best describes your answer. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, VR 12, Version 1.2 – October 1, 2013                                                                Form 04, Page 1 of 3 
 

Form 04 – Veterans Rand 12 Item Health Survey  
 
 
VISIT NO.          SITE NO.                     SUBJECT ID                          ALPHA CODE           
 
 
 
 
 
 
 
 
 
 4. 
During the past 4 weeks, have you had any of the following problems with 
 your work or other regular daily activities as a result of any emotional problems (such as feeling 
depressed or anxious)?   
 
 
 
No, 
None 
 of the 
 Time 
 
Yes, 
 a Little 
of the 
Time 
 
Yes, 
Some 
of the 
Time 
 
Yes, 
Most 
of the 
Time 
 
Yes,  
All 
of the 
Time 
 
a.  Accomplished less than you would like. 
 
 
 
 
 
 
 
 
 
 
 
b.  Didn’t do work or other activities as carefully as           
usual. 
 
 
 
 
 
 
 
 
 
 
 
 
 5. 
During the past 4 weeks, how much did pain interfere with your normal work 
(including both work outside the home and housework)? 
 
 
Not at all 
A little bit 
Moderately 
Quite a bit 
Extremely 
 
 
 
 
 
 
 
 
 
 
 
  
These questions are about how you feel and how things have been with you during 
the past 4 weeks.  For each question, please give the one answer that comes closest 
to the way you have been feeling. 
6. 
How much of the time during the past 4 weeks:                            
 
 
 
All 
of the 
Time 
 
Most 
of the 
Time 
 
A Good 
Bit of 
the 
Time 
 
Some 
of the 
Time 
 
A 
Little 
of 
the 
Time 
 
None 
of the 
Time 
 
a.  Have you felt calm and peaceful? 
 
 
 
 
 
 
 
 
 
 
 
 
 
b.  Did you have a lot of energy? 
 
 
 
 
 
 
 
 
 
 
 
 
 
c.  Have you felt downhearted and blue? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, VR 12, Version 1.2 – October 1, 2013                                                                Form 04, Page 2 of 3 
 

Form 04 – Veterans Rand 12 Item Health Survey  
 
 
VISIT NO.          SITE NO.                     SUBJECT ID                          ALPHA CODE           
 
 
 
 
 
 
 
 
 
 7. 
During the past 4 weeks, how much of the time has your physical health or 
emotional problems interfered with your social activities (like visiting with 
friends, relatives, etc.)?  
 
All of the time 
Most of the time 
Some of the time 
A little of the time 
None of the 
time 
 
 
 
 
 
 
 
 
 
 
 
 
Now, we’d like to ask you some questions about how your health may have changed. 
 
 8. 
Compared to one year ago, how would you rate your physical health in general now? 
 
 
Much better 
Slightly better 
About the same 
Slightly worse 
Much worse 
 
 
 
 
 
 
 
 
 
 
 
 
 9. 
Compared to one year ago, how would you rate your emotional problems (such as feeling 
anxious, depressed or irritable) now? 
 
 
Much better 
Slightly better 
About the same 
Slightly worse 
Much worse 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, VR 12, Version 1.2 – October 1, 2013                                                                Form 04, Page 3 of 3 
 

Form 05 – Intraoperative Data Collection  
                                                                                                        
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
FORM 05 – INTRAOPERATIVE DATA COLLECTION 
 
Complete Form BEFORE Leaving the Operating Room 
 
KEY INTRAOPERATIVE TIMEPOINTS (EVH and OVH CASES)  (Note: use Military time) 
 
 
1. Date of Surgery:  
                                         month            day                    year 
 
2. Patient arrives in operating room:  ................................................................................  
 
3. Chest skin incision start time:  .......................................................................................  
 
4. Leg skin incision start time:  ...........................................................................................  
 
5. Vein COMPLETELY REMOVED from leg tunnel/wound, placed in solution:  .................  
 
6. Vein FULLY PREPPED and ready for use as graft:  ..........................................................  
 
7. Vein handed up to surgeon for suturing to graft site:  ..................................................  
 
8. Cardiopulmonary bypass initiated (on-pump):  .............................................................  
 
9. Aortic cross-clamp applied:  ...........................................................................................  
 
10. Aortic cross-clamp removed:  ......................................................................................  
 
11. Cardiopulmonary bypass discontinued (off-pump):  ...................................................  
 
12. Surgery end-time:  .......................................................................................................  
 
13. Patient departs from operating room:  .......................................................................  
 
 
 
 
 
 
 
: 
: 
: 
: 
: 
: 
: 
: 
: 
: 
: 
: 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 1 of 9 
 
 

Form 05 – Intraoperative Data Collection  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
PRE-PROCEDURE DATA (EVH and OVH) 
 
14. Vein mapping performed:   
No 
 
Yes 
 
a. If yes, performed by:   
Technician 
Mid-Level Provider 
Surgeon 
 
b. if yes, when:                               PREOPERATIVELY 
 
INTRAOPERATIVELY  
 
c. if Preoperatively, when:   
Prior to Day of Surgery (DOS)         
 
DOS – Prior to Induction of Anesthesia 
 
DOS – Following Induction of Anesthesia 
 
15. Pre-op IV heparin:  
 
No 
 
Yes  (If No, proceed to question 16) 
 
 
a. If discontinued, date:                                                                                     
 
 
 
                  month            day                    year 
 
b. If discontinued, time:  
 
 
       (military time) 
 
16. Baseline activated clotting time (ACT):                             seconds 
 
17. Central venous pressure (CVP): 
 
 
      mmHg 
 
18. PaCO2: 
 
 
 
 
 
       mmHg 
 
19. ETCO2: 
 
 
 
 
 
       mmHg 
 
20.  FiO2:                                                            .                  % 
 
21.  PO2:                                                                                         mmHg 
 
22. EVH initiated:  
 
 
No 
 
Yes 
(If, NO skip to Q32) 
 
 
 
: 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 2 of 9 
 
 

Form 05 – Intraoperative Data Collection  
 
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                       
 
ENDOSCOPIC HARVEST DATA 
 
23. Prophylactic IV heparin bolus IMMEDIATELY PRIOR TO EVH:  
 
No 
 
Yes 
 
 
a. If YES, dosage amount: 
b. If NO, provide reason:  
 
 
ACT already therapeutic 
 
Pre-op Plavix use  
 
 
Thrombocytopenia  
 
Other, specify_______________________ 
24. EVH system: 
 
 
 
VasoView with HemoPro I (Maquet) 
 
 
VirtuoSaph (Terumo)  
 
 
 
VasoView with HemoPro II (Maquet) 
 
 
VirtuoSaph Plus (Terumo)  
 
 
  
VasoView with Bipolar (Maquet) 
 
 
Other, Specify___________________ 
 
 
a. If HemoPro, give setting: 
 
 
thermal units                                                                                     
 
 
 
                   
 
b. If Bipolar, give setting: 
 
 
watts 
 
25. CO2 flow rate: 
 
 
  
 
liters/min  
 
26. CO2 max pressure: 
   
 
 
mmHg 
 
27. PaCO2 (mid-procedure): 
 
 
 
mmHg 
 
28. ETCO2 (mid-procedure): 
 
 
 
mmHg 
 
29.  FiO2 (mid-procedure):                             .                     % 
 
30.  PO2 (mid-procedure):                                                    mmHg 
 
31. Conversion to open harvest procedure:  
 
No 
 
Yes 
(If, NO than Q54=0) 
 
 
OPEN HARVEST DATA (Randomization and Conversion) 
 
32. OVH performed:   
No 
 
Yes, for randomization  
Yes, for conversion  
 
 
 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 3 of 9 
 
 

Form 05 – Intraoperative Data Collection  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
33. Type of incision:   
  
 
Single/long 
 
 
 
Multiple/bridging 
 
 
 
Other, specify ___________________________ 
 
34.  Number of incision(s): 
 
35. Length of cumulative incision(s):  
     
cm  (Note:  add total length of incisions – not the bridging) 
 
36. Flap created:  
No 
 
Yes 
 
  
 
37. Device used:  
No 
 
Yes 
 
a. If YES, type:   
Storz 
 
 
 
Direct View Retractor  
 
 
 
Other, specify ___________________________ 
 
38. PaCO2 (mid-procedure): 
 
 
 
mmHg 
 
39. ETCO2 (mid-procedure): 
 
 
 
mmHg 
 
40.  FiO2 (mid-procedure):                             .                     % 
 
41.  PO2 (mid-procedure):                                                    mmHg 
 
POST-HARVEST DATA (EVH and OVH CASES) 
 
42. Vein storage solution composition: 
 
 
 
GALA 
 
 
 
 
 
Heparinized blood  
 
 
  
NSS 
 
 
 
 
 
Other, specify_______________________ 
 
 
  
Heparinized blood with papaverine 
 
43. Pressure-limiting syringe used to distend vein: 
 
No 
 
Yes 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 4 of 9 
 
 

Form 05 – Intraoperative Data Collection  
 
        SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
 
 
44. Total # repairs to EVH vein segment: 
 
45. Total # repairs to OVH vein segment: 
 
46. PaCO2: 
 
 
 
 
 
 
             mmHg 
 
47. ETCO2: 
 
 
      
 
 
 
             mmHg 
 
48.  FiO2:                                                                                       .                     % 
 
49.  PO2:                                                                                                              mmHg 
   
50. Intra-Aortic Balloon Pump Inserted? 
 
 
 
No 
 
 
 
 
 
Yes, INTRA-operatively  
 
 
  
Yes, PRE-operatively 
 
 
 
Yes, POST-operatively  
 
 
  
 
 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 5 of 9 
 
 

Form 05 – Intraoperative Data Collection  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
PRIMARY VEIN HARVESTER TO COMPLETE PROCEDURE MAP BELOW FOR ALL CASES (EVH and OVH) 
*Primary vein harvester is the person who spends the greatest amount of time performing the vein harvest procedure;  
  if two people perform equal harvest time then identify the harvester who initiated the procedure. 
GSV=Greater Saphenous Vein 
 
COMPLETE ENTIRE COLUMN FOR EACH VEIN GRAFT HARVESTED ON THE RIGHT: 
VEIN HARVEST PROCEDURE MAP 
RIGHT 
a. GSV Thigh 
b. GSV Calf 
c. Other Vein 
51. Vein harvest site: 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
52. Vein harvester: 
 
 
If 5, ______________ 
 
 
If 5, ______________ 
 
 
If 5, ______________ 
53. Vein harvest method 
 
EVH 
 
OVH 
 
 
EVH 
 
OVH 
 
 
EVH 
 
OVH 
 
54. Conversion from EVH to OVH: 
 
 
If 9, ______________ 
 
 
If 9, ______________ 
 
 
If 9, ______________ 
55. Harvest site closure by: 
 
 
If 6, ______________ 
 
 
If 6, ______________ 
 
 
 
If 6, ______________ 
56. Skin closure technique: 
 
 
If 6, ______________ 
 
 
If 6, ______________ 
 
 
If 6, ______________ 
57. Drain use: 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
58. Hematoma: 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
                                                                                 
  
 
 
 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 6 of 9 
 
 

Form 05 – Intraoperative Data Collection  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                        
 
 
COMPLETE ENTIRE COLUMN FOR EACH VEIN GRAFT HARVESTED ON THE LEFT: 
 
VEIN HARVEST PROCEDURE MAP 
LEFT 
d. GSV Thigh 
e. GSV Calf 
f. Other Vein 
51. Vein harvest site: 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
52. Vein harvester: 
 
 
If 5, ______________ 
 
 
If 5, ______________ 
 
 
If 5, ______________ 
53. Vein harvest method 
 
EVH 
 
OVH 
 
 
EVH 
 
OVH 
 
 
EVH 
 
OVH 
 
54. Conversion from EVH to OVH: 
 
 
If 9, ______________ 
 
 
If 9, ______________ 
 
 
If 9, ______________ 
55. Harvest site closure by: 
 
 
 
 
If 6, ______________ 
 
 
 
 
 
If 6, _______________ 
 
 
 
 
 
If 6, ______________ 
 
56. Skin closure technique: 
 
 
If 6, ______________ 
 
 
If 6, ______________ 
 
 
If 6, ______________ 
57. Drain use: 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
58. Hematoma: 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
 
No 
 
Yes 
 
                                                                                                            
 
 
 
 
 
 
 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 7 of 9 
 
 

Form 05 – Intraoperative Data Collection  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                      
 
STUDY SITE SURGEON TO COMPLETE CABG PROCEDURE MAP BELOW FOR ALL CASES (EVH and OVH) *See Codes* 
 
COMPLETE AN ENTIRE COLUMN FOR EACH BYPASS (a.= 1st bypass constructed, b.=2nd bypass, c.=3rd bypass).  
 
GRAFT 
a. 
b. 
c. 
59.  Bypass graft completed as 
        indicated on Form 2, Q54 
 
       No              Yes 
If No, provide reason 
 
 
If 4, _______________ 
 
       No              Yes 
If No, provide reason 
 
 
If 4, _______________ 
 
       No              Yes 
If No, provide reason 
 
 
If 4, _______________ 
60. Conduit source: 
 
 
If 4 or 9, 
______________ 
 
 
If 4 or 9, 
______________ 
 
 
If 4 or 9, 
______________ 
61. Harvest method: 
 
 
 
 
 
 
62. Conduit quality: 
 
 
If 3 or 8, 
 ______________ 
 
 
If 3 or 8, 
 ______________ 
 
 
If 3 or 8, 
 ______________ 
63. Conduit size: (mm) 
 
 
 
 
64. Proximal site: 
 
 
 
 
 
 
65. CASS site: 
 
 
 
66. Distal target size:  
 
 
 
 
 
 
67. Distal disease: 
 
 
 
 
 
 
68. Distal anastomosis: 
 
       Attending Surgeon 
 
       Resident/Fellow 
 
       Attending Surgeon 
 
       Resident/Fellow 
 
       Attending Surgeon 
 
       Resident/Fellow 
                                                                                                           
 
 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 8 of 9 
 
 

Form 05 – Intraoperative Data Collection  
          SITE NO.           SUBJECT ID. 
    ALPHA CODE           
                                                                                                                      
 
COMPLETE AN ENTIRE COLUMN FOR EACH BYPASS (d.= 4th bypass constructed; e.= 5th bypass; f.= 6th bypass) 
 
GRAFT 
d. 
e. 
f. 
59.  Bypass graft completed as 
        indicated on Form 2, Q54 
 
       No              Yes 
If No, provide reason 
 
 
If 4, _______________ 
 
       No              Yes 
If No, provide reason 
 
 
If 4, _______________ 
 
       No              Yes 
If No, provide reason 
 
 
If 4, _______________ 
60. Conduit source: 
 
 
If 4 or 9, 
______________ 
 
 
If 4 or 9, 
______________ 
 
 
If 4 or 9, 
______________ 
61. Harvest method: 
 
 
 
 
 
 
62. Conduit quality: 
 
 
If 3 or 8, 
 ______________ 
 
 
If 3 or 8, 
 ______________ 
 
 
If 3 or , 
 ______________ 
63. Conduit size: (mm) 
 
 
 
 
64. Proximal site: 
 
 
 
 
 
 
65. CASS site: 
 
 
 
66. Distal target size:  
 
 
 
 
 
 
67. Distal disease: 
 
 
 
 
 
 
68. Distal anastomosis: 
 
       Attending Surgeon 
 
       Resident/Fellow 
 
 
       Attending Surgeon 
 
       Resident/Fellow 
 
 
       Attending Surgeon 
 
       Resident/Fellow 
 
 
 
S.I. Signature ________________________________________             Date ___________________ 
 
    
 
 
CSP#588 – REGROUP, Intraoperative Data Collection, Version 1.2 – October 1, 2013 
 
         Form 05, Page 9 of 9 
 
 

 
 
*Primary vein harvester is the person who spends the greatest amount of time performing the vein harvest procedure;  
  if two people perform equal harvest time then identify the harvester who initiated the procedure. 
 
 
 
 
 
 
VEIN HARVEST CODES 
52. Primary Vein Harvester* 
53. Method of Vein Harvest: 
54. Conversion from EVH to OVH r/t: 
1= PA-C 
2= CRNP/CRNFA 
3= Attending  Surgeon 
4= Resident/Fellow 
5= other 
EVH= Endoscopic   
OVH= Open 
 
0= NOT APPLICABLE (if 0 then #31=NO) 
1= Bleeding                (if 1-9 then #31 =YES) 
2= Injury to SVG 
3= Unacceptable EVH procedure time 
4= Insufficient amount of usable  
     vein from EVH procedure 
5= Unanticipated graft needed requiring   
      additional vein taken open 
6= Harvester unable to locate vein 
7= Equipment issue (i.e. contamination,  
      failure, availability) 
8= Patient becomes unstable 
9= other 
55. Harvest Site Closure By: 
56. Skin Closure Technique: 
1= Primary Vein Harvester (#52) 
2= other PA-C 
3= other CRNP/CRNFA 
4= other Attending surgeon 
5= other Resident/Fellow 
6= other 
1= Subcuticular suture 
2= Staples 
3= Steristrips 
4= Dermabond 
5= Combination of above 
6= other 
CABG CODES 
59. BYPASS NOT   
      COMPLETED AS  
      INDICATED AT  
      BASELINE (Form 2) 
60. CONDUIT  SOURCE 
61. HARVEST  
       METHOD 
62. QUALITY OF VEIN CONDUIT USED FOR GRAFTING  
        (if Arterial, leave blank) 
1= Target too Small 
2= Diffuse Disease 
3= Inadequate Conduit 
4= other 
ARTERIAL: 
1= LIMA 
2= RIMA 
3= Radial  
4= other 
VENOUS: 
5= Right 
Thigh 
6= Right Calf 
7= Left Thigh 
8= Left Calf 
9= other 
1= Arterial 
2= EVH 
3= OVH 
DOES NOT INCLUDE DISCARDED VEIN 
1= Good (ideal vein with uniform caliber, few branches)  
2= Intermediate (usable vein but sclerotic, non-distensible) 
3= Intermediate d/t OTHER specify ________________________          
4= Poor d/t THIN VEIN 
5= Poor d/t VARICOSE VEIN 
6= Poor d/t DE-SEROSALIZED WALL from MECHANICAL INJURY 
7= Poor d/t THERMAL INJURY 
8= Poor d/t OTHER specify_______________________________  
63. VEIN CONDUIT SIZE (if Arterial, leave blank)  
Estimate to closest mm after vein is distended. 
64. PROXIMAL SITE 
66. DISTAL 
TARGET SIZE 
67. DISTAL TARGET DISEASE 
68. DISTAL TARGET ANASTOMOSIS 
1= Ascending Aorta             4= RIMA                                 
2= Pedical IMA (In-situ )     5= SVG                   
3= LIMA                         
1= <1.5mm 
2= 1.5-2.0mm 
3= >2.0mm 
0= None              3= Severe 
1= Mild               4= Endarterectomy 
2= Moderate 
Who performed distal anastomosis? 
Attending Surgeon 
Resident/Fellow 
65. CASS SITE (DISTAL TARGET) 
1= Prox RCA            6= 1st RPL                         
11= LMCA                    
16= 2ndDiag 
21= 2nd OM            
26= 3rd LPL        
2= Mid RCA             7= 2nd RPL                        
12= Prox LAD              
17= 1stSeptal          
22= 3rd OM            
27= LPDA                           
3= Dist RCA             8= 3rd RPL                         
13= Mid LAD 
18= Prox Cx           
23= Dist Cx           
28= RAMUS                                       
4= RPDA                  9= Inferior Septal  
14= Dist LAD               
19= Mid Cx              
24= 1st LPL            
29= 3rdDiag 
5= RPAV                 
10= Acute Marginal        
15=1stDiag 
20= 1st OM             
25= 2nd LPL           
30= Unknown 
 
    
 
 
 
 
 

Form 06 – Postoperative Assessments  
                                                                                                           
SITE NO. 
        SUBJECT ID                             ALPHA CODE                         DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day 
Year 
 
FORM 06 – POSTOPERATIVE ASSESSMENTS 
 
 
 
1. POST-OP DAY #1 ................................................................... 
month            day                    year 
 
2. ECG evidence of new pathologic Q waves or new LBBB:  ....................................   No               Yes     
If yes, obtain Cardiac Biomarkers of choice every 8 hours until downward trend is seen in level and 
complete A, B, OR C below. 
 
A.  Peak Cardiac Troponin I 
1. Peak Cardiac Troponin I (ng/mL):  ..............................................                     .  
2. Reference Range (ng/mL)  ..................................           .                   to            . 
B. Peak Cardiac Troponin T 
1. Peak Cardiac Troponin T (ng/mL):  .............................................                     . 
2. Reference Range (ng/mL)  ..................................           .                   to            . 
C. Peak CPK/MB Panel 
1. Peak Total CPK (U/L):  .................................................................   
2. Total CPK Reference Range (U/L)  .....................................                  to 
AND 
3. Peak CK-MB (ng/mL): ........................................................................                    . 
4. CK-MB Reference Range (ng/mL)  ................................................            to          . 
AND 
5. Peak CK-MB Index (%):  .....................................................................                    . 
6. CK-MB Index Reference Range (%)  ....................................           .           to          .           
3. ECG evidence of arrhythmia:  ...............................................................................   No                Yes         
1. If yes, specify:                  atrial fibrillation 
                                           atrial flutter 
                                           pacemaker 
 
                             
                                           other, specify___________________ 
 
4. Chest tube drainage (cc):  ..........................................................................................  
 
 
 
CSP#588 - REGROUP, Postoperative Assessments, Version 1.2 – October 1, 2013                Form 06, Page 1 of 4 
 
 

Form 06 – Postoperative Assessments  
 
SITE NO. 
             SUBJECT ID 
                ALPHA CODE       
 
 
 
 
 
 
 
5. Leg incision drainage (cc) (if applicable):  ..................................................................  
 
6. Leg incision dressings (number of changes):  .........................................................................  
 
7. Blood/Products Transfusion:  ...............................................................................   No               Yes     
 
1. If yes, check all that apply:          PRBCs 
                                                         FFP 
                                                         Platelets 
 
                             
                                                         Cryoprecipate 
8. Intra-aortic balloon pump:  ..................................................................................   No               Yes     
    
9. ECMO:  ...................................................................................................................   No               Yes     
 
10. Ventricular Assist Device:   ............................................................................................  No                 Yes     
 
 
 
 
CSP#588 - REGROUP, Postoperative Assessments, Version 1.2 – October 1, 2013                Form 06, Page 2 of 4 
 
 

Form 06 – Postoperative Assessments  
SITE NO. 
             SUBJECT ID 
                ALPHA CODE       
 
 
 
 
 
 
 
11. POST-OP DAY #2 ......................................................................  
   month            day                    year 
 
12. ECG evidence of new pathologic Q waves or new LBBB:  ....................................   No               Yes     
If yes, obtain Cardiac Biomarkers of choice every 8 hours until downward trend is seen in level and 
complete A, B, OR C below. 
 
A.  Peak Cardiac Troponin I 
1. Peak Cardiac Troponin I (ng/mL):  ..............................................                     .  
2. Reference Range (ng/mL)  ..................................           .                   to            . 
B. Peak Cardiac Troponin T 
3. Peak Cardiac Troponin T (ng/mL):  .............................................                     . 
4. Reference Range (ng/mL)  ..................................           .                   to            . 
C. Peak CPK/MB Panel 
7. Peak Total CPK (U/L):  .................................................................   
8. Total CPK Reference Range (U/L)  .....................................                  to 
AND 
9. Peak CK-MB (ng/mL): ........................................................................                    . 
10. CK-MB Reference Range (ng/mL)  ................................................            to          . 
AND 
11. Peak CK-MB Index (%):  .....................................................................                    . 
12. CK-MB Index Reference Range (%)  ....................................           .           to          .           
 
 
 
                
13. ECG evidence of arrhythmia:  ...............................................................................   No               Yes         
 
1. If yes, specify:          atrial fibrillation 
                                    atrial flutter 
                                    pacemaker 
 
                         
                                    other, specify___________________ 
 
14. Chest tube drainage (cc):  .........................................................................................  
 
CSP#588 - REGROUP, Postoperative Assessments, Version 1.2 – October 1, 2013                Form 06, Page 3 of 4 
 
 

Form 06 – Postoperative Assessments  
 
SITE NO. 
             SUBJECT ID 
                ALPHA CODE       
 
 
 
 
 
15. Leg incision  drainage (cc) (if applicable):  ................................................................ 
 
16. Leg incision dressings (number of changes):  .........................................................................  
 
17. Blood/Products Transfusion:   ..............................................................................   No               Yes     
 
1. If yes, check all that apply:          PRBCs 
                                                          FFP 
                                                          Platelets 
         
                                                          Cryoprecipate 
 
 
18. Intra-aortic balloon pump:  ..................................................................................   No               Yes     
 
19. ECMO:   ..................................................................................................................   No               Yes     
 
20. Ventricular Assist Device:   ...................................................................................   No               Yes    S.I 
 
 
 
 
 
S.I. Signature ________________________________________             Date ___________________ 
CSP#588 - REGROUP, Postoperative Assessments, Version 1.2 – October 1, 2013                Form 06, Page 4 of 4 
 
 

Form 07 – Postoperative and Discharge Assessment  
                                                                                                           
SITE NO. 
        SUBJECT ID                             ALPHA CODE                         DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day 
Year 
 
FORM 07 – DISCHARGE ASSESSMENT 
 
 
 
 
 
  
1. Date of Discharge  ..............................................................................  
                month           day             year 
 
2. Endotracheal tube extubation (final) > POD #2    No           Yes 
                                                                                                                              month          day             year       
 
3. Inotropic Agents > POD #2::  ................................................................................   No               Yes     
 
 If yes, check all that apply:                 Dopamine 
                                            Dobutamine 
                                            Epinephrine 
                                            Norepinephrine 
 
Amrinone 
 
Milrinone 
 
                             
                                           other, specify___________________ 
 
4. Transfer order to step down (final) > POD #3      No           Yes 
                                                                                                                              month          day             year       
 
5. Discharge order > 7 days of initial CABG               No           Yes 
                                                                                                                              month          day             year 
 
6. Creatinine (mg/dL)  ...................................................              .  
                                                                                                                              month          day             year 
 
7. Potassium (mEq/L) ...................................................              .    
                                                                                                                              month          day             year 
 
8. White Blood Cell Count (103/mm3) .............                   .  .  
                                                                                                                             month          day             year 
9. Hematocrit (%)    ..................................................                     . 
                                                                                                                              month          day             year       
 
S.I. Signature ________________________________________             Date ___________________ 
 
 
 
CSP#588 - REGROUP, Discharge Assessments, Version 1.2 – October 1, 2013                        Form 07, Page 1 of 1 
 
 

Form 08 – Leg Incision Pain Impact Questionnaire – Discharge Assessment 
 
 
SITE NO. 
        SUBJECT ID                              ALPHA CODE                         DATE OF ASSESSMENT 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
FORM 08 – LEG INCISION PAIN IMPACT QUESTIONNAIRE - DISCHARGE ASSESSMENT 
1. How much leg incision pain have you had during the past week? 
 
None              Very mild            Mild             Moderate              Severe            Very severe 
   
 
 
2. During the past week, how much did leg incision pain interfere with your normal activity? 
 
Not at all                A little bit            Moderately             Quite a lot              Extremely 
 
 
 
3. In the past week, how much of the time did leg incision pain interfere with your enjoyment of 
life?  
    Never                       Rarely                  Sometimes            Very often                  Always 
 
 
 
4. In the past week, how often did leg incision pain make simple tasks hard to complete? 
 
    Never                      Rarely                  Sometimes             Very often                    Always 
 
 
 
5. In the past week, how often were your leisure activities affected by your leg incision pain 
(including exercise and hobbies)? 
    Never                       Rarely                  Sometimes             Very often                  Always 
 
 
 
6. In the past week, how often did leg incision pain make you feel fed up and frustrated? 
 
    Never                       Rarely                  Sometimes             Very often                 Always 
 
 
 
 
CSP#588 - REGROUP, Leg Incision Pain - Discharge  Version 1.2 – October 1,2013         Form 08, Page 1 of 1 

Form 09 – Leg Incision Pain Impact Questionnaire – 6 Week Assessment  
 
 
SITE NO. 
        SUBJECT ID                          ALPHA CODE                    DATE OF ASSESSMENT 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                        Year 
FORM 09 – LEG INCISION PAIN IMPACT QUESTIONNAIRE 
6-WEEK POSTOPERATIVE ASSESSMENT 
1. How much leg incision pain have you had during the past 4 weeks? 
 
None              Very mild            Mild              Moderate             Severe            Very severe 
   
 
 
2. During the past 4 weeks, how much did leg incision pain interfere with your normal activity? 
 
Not at all               A little bit            Moderately              Quite a lot              Extremely 
 
 
 
3. In the past 4 weeks, how much of the time did leg incision pain interfere with your enjoyment of 
life?  
    Never                    Rarely                 Sometimes              Very often               Always 
 
 
 
4. In the past 4 weeks, how often did leg incision pain make simple tasks hard to complete? 
    Never                    Rarely                 Sometimes               Very often               Always 
 
 
 
5. In the past 4 weeks, how often were your leisure activities affected by your leg incision pain 
(including exercise and hobbies)? 
    Never                    Rarely                 Sometimes               Very often               Always 
 
 
 
6. In the past 4 weeks, how often did leg incision pain make you feel fed up and frustrated? 
 
    Never                    Rarely                 Sometimes               Very often               Always 
 
 
 
 
CSP#588 - REGROUP, Leg Incision Pain – 6 Week Version 1.2 – October 1, 2013          Form 09, Page 1 of 1 

Form 10 – Leg Incision Assessment   
                                                                                         
 
 
 SITE NO.                SUBJECT ID 
   ALPHA CODE                          
 
 
 
 
 
 
 
 
 
  
                                 
 
FORM 10 – LEG INCISION ASSESSMENT 
 
 
ASEPSIS SCORE CRITERIA 
 
RATE BY EXTENT FOR 1 WEEK AT TIME OF DISCHARGE – Date of Assessment: 
 
 
 
  
                                                      Month 
Day 
Year 
 
1. Serous exudates: 
 
  
 
 
0  
1 
2 
3 
4 
5 
  
 
             None 
 
 
 
           Severe 
 
 
2. Erythema: 
  
 
 
0  
1 
2 
3 
4 
5 
  
 
             None 
 
 
 
           Severe 
 
 
3. Purulent exudates: 
 
  
 
 
0  
1 
2 
3 
4 
5 
6 
7 
8 
9           10 
  
 
             None 
 
 
 
             
 
 
                        Severe 
 
4. Separation of tissues:  
  
 
 
0  
1 
2 
3 
4 
5 
6 
7 
8 
9           10 
  
 
             None 
 
 
 
             
 
 
                        Severe 
 
RATE BY EXTENT FOR 4-6 WEEKS AT TIME OF FOLLOW-UP VISIT – Since Discharge 
 Date of Assessment:  
 
 
 
  
 
 
              Month 
Day 
Year 
 
5. Antibiotics:  ...............................................................................................................  
 No = 0            Yes=10 
  
 
 
 
 
 
 
 
 
 
 
 
              
 
 
 
 
                       
6. Drainage under local anesthetic:  .............................................................................  
 No = 0            Yes=5 
  
     
7. Debridement under general anesthetic:  .................................................................  
 No = 0            Yes=10 
 
 
8. Bacterial isolation:  ...................................................................................................  
 No = 0            Yes=10 
  
   
 
 
 
 
CSP#588 – REGROUP, Leg Incision Assessment, Version 1.2 – October 1, 2013  
 
 
           Form 10, Page 1 of 2 
 
 

Form 10 – Leg Incision Assessment   
                                                                                                           
 SITE NO.                 SUBJECT ID 
               ALPHA CODE           
  
 
 
 
 
 
 
9. Hospital stay prolonged >14 days:  (if yes, complete Form 15 – SAE) ......................             No = 0              Yes=5 
 
 
10. Development of pus as an outpatient:   .................................................................  
 No = 0              Yes=5 
  
 
 
11. Visiting nurse visit to dress wound:  .......................................................................             No = 0             Yes=5 
 
 
12.  Asepsis Score Total > 10 INDICATES WOUND INFECTION                                                          Score 
        (Total of Questions 1-11) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
S.I. Signature ________________________________________             Date ___________________ 
 
 
CSP#588 – REGROUP, Leg Incision Assessment, Version 1.2 – October 1, 2013  
 
 
           Form 10, Page 2 of 2 
 
 

Form 11 – 6 Week MACE Event Form  
 
 
 
SITE NO. 
        SUBJECT ID                              ALPHA CODE                         DATE OF VISIT 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
FORM 11 – 6 WEEK MACE EVENT FORM 
 
 
 
 
1.   
Has the subject died after the last contact?  ...........................................................  No               Yes 
               (If yes, complete Forms 14 and 15) 
 
a. 
Date of death  .................................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
2. 
Did the subject have an acute myocardial infarction since the last contact?  .........  No               Yes 
               (If yes, complete form 15 and 19) 
 
a. 
AMI Date  ........................................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
3. 
Did the subject receive PCI since the last contact?   ................................................   No               Yes 
If yes, 
 
a. 
Procedure Date  ..............................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
4. 
Did the subject receive CABG since the last contact?   ............................................   No               Yes 
 
If yes,  
  
a. 
Procedure Date  ..............................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
 
For Q 1-4 answered yes, obtain appropriate medical records for required source documentation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, 6 Week MACE Event, Version 1.2 – October 1, 2013                                       Form 11, Page 1 of 2 

Form 11 – 6 Week MACE Event Form  
 
SITE NO. 
        SUBJECT ID                              ALPHA CODE           
 
 
 
 
 
 
 
 
 MEDICATIONS 
 
5.    Has the subject taken any of the following medications in since last contact?      
 
a. Beta blocker   ......................................................................................    No              Yes 
b. ACE/ARB Inhibitor   .............................................................................    No              Yes 
c. Statin   .................................................................................................    No              Yes 
d. Non-Statin LLA   ..................................................................................    No              Yes 
e. Nitrate  ................................................................................................    No              Yes 
f. 
Calcium Channel Blocker   ..................................................................    No              Yes 
g. Aspirin   ...............................................................................................    No              Yes 
h.    Plavix  .................................................................................................    No              Yes 
i.     Warfarin  .............................................................................................    No              Yes 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Form Completed By _____________________________________________   Date  ___________________________ 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, 6 Week MACE Event, Version 1.2 – October 1, 2013                                       Form 11, Page 2 of 2 

Form 12 – Phone Call Follow-up  
 
 
 
VISIT (Months)             SITE NO. 
            SUBJECT ID 
                             ALPHA CODE                          
 
 
 
 
 
 
 
FORM 12 – PHONE CALL FOLLOW-UP FORM 
 
 
 
1. 
Date of phone call (or medical chart review)  ..............................  
 
 
 
  
 
 
 
Month 
Day                  Year 
 
2.   
Subject contacted successfully?  ..............................................................................   No              Yes 
    
3.   
Did the subject die since the last contact?   .............................................................   No              Yes 
               If yes, (complete Forms 14 and 15) 
 
a. 
Date of death  .................................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
4. 
Did the subject have an acute myocardial infarction since the last contact?  .........  No              Yes  
              If yes, (complete form 15 and 19) 
 
a. 
AMI Date  ........................................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
5. 
Did the subject receive PCI since the last contact?   ................................................   No              Yes 
If yes, 
 
a. 
Procedure Date  ..............................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
6. 
Did the subject receive CABG since the last contact?  .............................................  No               Yes 
 
If yes,  
  
a. 
Procedure Date  ..............................................................  
 
 
 
  
 
 
             Month              Day                  Year 
 
For Q 3-6 answered yes, obtain appropriate medical records for required source documentation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Phone Call Follow-up, Version 1.2 – October 1, 2013                                      Form 12, Page 1 of 2 

Form 12 – Phone Call Follow-up  
 
 
VISIT (Months)             SITE NO. 
            SUBJECT ID 
                             ALPHA CODE                          
 
 
 
 
 
 
 
 
 
 MEDICATIONS 
 
7.    Has the subject taken any of the following medications since last contact or review?      
 
a. Beta blocker   .....................................................................................    No               Yes 
b. ACE/ARB Inhibitor   ............................................................................    No               Yes 
c. Statin  .................................................................................................    No               Yes 
d. Non-Statin LLA   .................................................................................    No               Yes 
e. Nitrate  ...............................................................................................    No               Yes 
f. 
Calcium Channel Blocker  ..................................................................    No               Yes 
g. Aspirin  ...............................................................................................    No               Yes 
h.    Plavix    ...............................................................................................    No               Yes 
i.     Warfarin  ............................................................................................    No               Yes 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Form Completed By ______________________________________________  Date ___________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Phone Call Follow-up, Version 1.2 – October 1, 2013                                      Form 12, Page 2 of 2 

Form 14 – Study Completion/Termination  
 
       
VISIT NO.         SITE NO.                 SUBJECT ID                       ALPHA CODE                         DATE OF ASSESSMENT 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
FORM 14 – STUDY COMPLETION/TERMINATION 
 
                            
1. Using the list below, mark an (x) in the box that best describes the subject’s status at the end of the 
study (mark only one): 
 
    
Subject completed study 
 
Subject voluntarily withdrew  
 
Subject lost to follow-up (location unknown) 
 
Other, specify _____________________________________________________________ 
 
Subject died – Complete Serious Adverse Event Form 15 and record SAE#: 
 
 
Date of Death:  ...............................................................  
                                                                                                                              Month            Day           Year               
Cause of Death: 
a. Specific cause of death (based on review of available medical chart data) 
____________________________________________________________________ 
____________________________________________________________________ 
b. Primary cause of death was most likely 
          Cardiac related 
           Not cardiac related 
           Unknown 
c. Detailed information about primary cause of death by category 
            Accident                                        Cerebrovascular 
             Suicide                                           Pulmonary 
             Infection                                        Cancer 
             Cardiovascular                              Other 
 
S.I. Signature __________________________________         Date _____________________________ 
CSP#588 - REGROUP, Study Completion/Termination, Version 1.2 – October 1, 2013                 Form 14, Page 1 of 1 

Form 15 – Serious Adverse Event  
 
 
 
 
SAE#             SITE NO.                       SUBJECT ID                       ALPHA CODE                  DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
 
FORM 15 – SERIOUS ADVERSE EVENT 
 
 
1. 
Start Date (date the SAE began)  ................................................  
 
 
 
  
 
 
           Month         Day                  Year 
2. 
Serious event type:  Check all that apply 
 
 
Death 
 
 
Life-threatening 
 
 
Inpatient hospitalization or prolongation of existing hospitalization 
                             Non fatal Myocardial Infarction 
 
 
Persistent or significant disability/Incapacity 
 
 
Any other condition that may jeopardize the subject and require medical or surgical  
 
 
treatment to prevent one of the above outcomes 
 
3. 
Date site investigator became aware of the event  ....................  
 
 
 
  
 
 
           Month         Day                 Year 
 
4. 
Is the SAE attributed to the study?  
                             Not Attributed                            Possibly Attributed 
           Definitely Attributed 
 
 
5. 
Brief description of the serious adverse event:  ________________________________________ 
_____________________________________________________________________________________ 
 
6. 
Detailed description of the serious adverse event; including treatment of the event (describe  
               subject’s condition just prior to, during and after the event.  If known, give the duration and  
               outcome of this event.  Do not include past medical history):  
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Serious Adverse Event, Version 1.2 – October 1, 2013                                   Form 15, Page 1 of 2 
 

Form 15 – Serious Adverse Event  
 
 
SAE#             SITE NO.                       SUBJECT ID                       ALPHA CODE                   
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
7. 
Pertinent medical history (include pre-existing medical conditions and relevant adverse events  
               previously reported):  
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
8. 
Pertinent Test Results/Laboratory Data (include abnormal and normal laboratory results/data  
               and the date(s) of these tests and/or procedures).  
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________ 
 
9. 
Outcome (mark only one) 
 
 Fatal, Date of Death:   ....................................................  
 
 
 
  
                                                 Month         Day        Year 
 
 
        Ongoing - Recovering/Resolving 
 
           Ongoing - Not Recovered/Resolved 
                          Recovered/Resolved, Date: ..........................................  
   
 
 
  
                                                   Month         Day       Year 
 
 
            Recovered/Resolved with Sequelae  
                          (no change expected), requires Stop Date: ..................  
 
 
 
  
 
 
            Month         Day       Year 
   
             Unknown 
 
10. 
Is a Follow-up Serious Adverse Event Form (Form 16) required?  ...................           No  
    Yes 
 
 
S.I. Signature ________________________________________             Date ___________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Serious Adverse Event, Version 1.2 – October 1, 2013                                   Form 15, Page 2 of 2 
 

Form 16 – Serious Adverse Event Follow-up 
 
 
 
 
SAE#      FOLLOW-UP #      SITE NO.           SUBJECT ID                    ALPHA CODE            DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
 
FORM 16 – SERIOUS ADVERSE EVENT FOLLOW-UP 
 
1. 
Start date of the original Serious Adverse Event (SAE)  ............. 
 
 
 
  
 
 
          Month          Day                  Year 
 
2. 
Has the diagnosis being reported changed from the initial SAE reported 
on Form 15?  ....................................................................................................            No               Yes 
If yes, new diagnosis _____________________________________________________________ 
 
3. 
Is there additional new information to report?   .............................................            No               Yes  
   
 If yes, specify ___________________________________________________________________ 
 
______________________________________________________________________________ 
 
______________________________________________________________________________ 
 
4. 
Has the SAE attributability to study surgery changed since the previous report?         No           Yes     
               If yes, is the event:    
  Not Attributed           Possibly Attributed           Definitely Attributed 
 
5. 
Outcome (mark only one) 
 
          Fatal, include Date of Death:  ...........................................  
 
 
 
  
                                                 Month         Day           Year 
 
 
        Ongoing - Recovering/Resolving 
 
              Ongoing - Not Recovered/Not Resolved 
                          Recovered/Resolved, Date:  ............................................. 
   
 
 
  
                                                 Month         Day               Year 
 
 
            Recovered/Resolved with Sequelae 
                           (no change expected), requires Stop Date:  .................... 
 
 
 
  
 
 
          Month         Day                 Year 
   
             Unknown 
6. 
Is another follow-up form expected for this SAE?        No              Yes   If yes, Follow-up # 
 
S.I. Signature ________________________________________             Date ___________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Serious Adverse Event Follow-up, Version 1.2 – October 1, 2013                Form 16, Page 1 of 1 
 

Form 17 – Harvester Experience 
 
              
SITE NO. 
        HARVESTER ID                                                                         DATE OF COMPLETION  
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
 
FORM 17 – SITE QUALIFICATION BY AVAILABILITY OF VEIN HARVESTER 
 
1. Name of Harvester ______________________________________________ 
 
2. Degree of Training 
 
 
PA-C 
 
CRNP 
 
MD 
 
Other, specify _____________________ 
3. Years of general experience after completion of formal training in chosen profession  
 
 
<5 years 
 
>5 years but <10 years 
 
>10 years 
 
4. Name of Supervising Physician……__________________________________________ 
 
5. I have done the following number of Endoscopic Vein Harvests (EVH) as of today’s date 
 
>100 but <500 
>500 but <1,000 
>1,000 but <2,000 
>2,000 
If <100 EVH: STOP! 
You are not eligible to participate in CSP #588 at this time. 
Please return this Form to Jennifer Gabany at the CSP 588 National Office 
 
6. I have expertise with the following EVH systems 
 
VasoView® (MAQUET) 
 
VirtuoSaph® (TERUMO) 
 
both 
 
 
 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Harvester Experience, Version 1.2 – October 1, 2013                  Form 17, Page 1 of 2 
 

Form 17 – Harvester Experience 
 
SITE NO. 
        HARVESTER ID 
                                                                          
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
7. Number of Open (without endoscope; including bridging technique) Vein Harvests (OVH) as of today’s date  
 
<50 
 
>50 but <100 
 
>100 but <500 
 
>500 but <1000 
 
>1000 but < 2000 
 
>2000 
8. My conversion Rate from EVH to OVH in Last 100 EVH Cases 
 
 
5% 
 
 
>3% but <5% 
 
 
>1% but <3% 
 
 
<1% 
 
 
 
 
9. The above Harvester is experienced in:                       both EVH and OVH                    EVH only 
 
 
Signature of Site Surgeon Investigator                      Printed Name of Site Surgeon Investigator 
_______________________________ 
_____________________________________ 
 
_________________ 
Date 
 
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Harvester Experience, Version 1.2 – October 1, 2013                  Form 17, Page 2 of 2 
 

Form 18 – Protocol Noncompliance  
 
 
 
EVENT NO.         SITE NO.                SUBJECT ID                   ALPHA CODE                    DATE OF NONCOMPLIANCE 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day                  Year 
 
 
FORM 18 – PROTOCOL NONCOMPLIANCE 
 
 
 
1. Noncompliance Code  ........................................................................................  
 
 
 
2. Details (cause of, result, resolution, etc.) 
 
______________________________________________________________________ 
 
______________________________________________________________________ 
 
______________________________________________________________________ 
 
______________________________________________________________________ 
 
______________________________________________________________________ 
 
______________________________________________________________________ 
 
3. Perry Point CSPCC notified on  ................................... 
                                                                                                                  Month            Day            Year 
4. IRB notified on  ........................................................... 
(code “A” if not notified, note reason in chart)               Month            Day            Year 
 
5. Chairman’s Office notified on  ...................................... 
                                                                                                                  Month            Day            Year 
  
      9.  Did the noncompliance result in a serious adverse event  .................... No           Yes 
 
(If yes, complete Form 15 – Serious Adverse Event Form) 
 
 
 
 
 
S.I. Signature ________________________________________             Date ___________________
 
 
 
 
 
 
 
 
 
CSP#588 - REGROUP, Protocol Noncompliance, Version 1.2 – October 1, 2013           Form 18, Page 1 of 1 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Noncompliance Codes 
 
01 
SAE not reported 
02 
SAE reported late 
03 
Subject not monitored for SAE 
04 
Did not follow instructions from IRB or other review bodies/committees 
05 
Confidentiality or privacy breach 
06 
Loss of source documents/samples/source media 
07 
Ineligible subject enrolled 
08 
Subject in more than one simultaneous interventional trial 
09 
Informed Consent/HIPAA documentation completed incorrectly 
10 
Informed Consent/HIPAA documentation is incomplete 
11 
Informed Consent/HIPAA not obtained prior to study procedures 
12 
Used incorrect informed consent/HIPAA version 
13 
Required study procedure not performed per protocol 
14 
Study activities performed by inappropriate personnel 
15 
Study intervention not administered per protocol 
16 
Subject noncompliance 
17 
Other (specify under Details of noncompliance 
 

Form 19 – Confirmation of Myocardial Infarction  
 
 
MI #          SITE NO.              SUBJECT ID                         ALPHA CODE                 DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day 
  Year 
 
FORM 19 – CONFIRMATION OF MYOCARDIAL INFARCTION BY LOCAL SITE 
 
 
1. Date of study surgery (index CABG)  ......................................  
                                                                                                               Month           Day                   Year               
2. Date of  myocardial infarction (MI)  .......................................  
                                                                                                               Month           Day                   Year               
3. Supporting documentation (universal definition of MI): 
 
      ECG Changes 
          All that apply 
 
 
          Development of new ST-T changes 
 
          Development of new LBBB 
 
          Development of new pathologic Q-Waves 
 
 
If any ECG changes marked above, you must complete A, B, OR C below 
A. Peak Cardiac Troponin I 
1.  Peak Cardiac Troponin I (ng/mL):                        .                
 
 
 
2.  Reference Range (ng/mL):              .                  to            . 
B. Peak Cardiac Troponin T 
1. Peak Cardiac Troponin T (ng/mL):                       .          
   
2. Reference Range (ng/mL)               .                   to            . 
C.  Peak CPK/MB Panel 
1. Peak Total CPK (U/L): 
 
                                                          
 
 
2. Total CPK Reference Range (U/L):                         to  
3.   Peak CK-MB (ng/mL):                                 .                                               
 
 
4.  
CK-MB Reference Range (ng/mL):                  to           . 
5.   Peak CK-MB Index (%):                             .                         
6. CK-MB Index Reference Range (%):             .           to            . 
 
 
 
CSP#588 - REGROUP, Confirmation of MI, Version 1.2 – October 1, 2013                      Form 19, Page 1 of 2 

Form 19 – Confirmation of Myocardial Infarction  
 
 
 MI #                SITE NO.                   SUBJECT ID                   ALPHA CODE           
 
 
 
 
 
 
 
4.      Other Supporting Documentation (check all that apply) 
 
        Imaging evidence of loss of viable myocardium or new regional wall motion abnormality 
 
        Symptoms of ischemia 
 
        Angiographic documenting new graft or new coronary occlusion 
 
 
 
 
 
S.I. Signature ________________________________________             Date ___________________ 
 
 
CSP#588 - REGROUP, Confirmation of MI, Version 1.2 – October 1, 2013                      Form 19, Page 2 of 2 

Form 20 – Classification of Myocardial Infarction  
 
 
MI #          SITE NO.              SUBJECT ID                         ALPHA CODE                 DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day 
  Year 
 
FORM 20 – CONFIRMATION OF MYOCARDIAL INFARCTION BY CLINICAL EVENTS COMMITTEE 
 
 
 
 
1.  Clinical Events Committee Confirms Diagnosis of Myocardial Infarction:     No               Yes 
If yes, proceed to question 2. 
If no, STOP, sign form and submit to the Perry Point Coordinating Center. 
 
2.  Classification of myocardial infarction: (select one) 
 
 
 
Type 1 Spontaneous myocardial infarction 
 
 
Type 2  Myocardial infarction secondary to an ischemic imbalance 
 
 
Type 3  Myocardial infarction resulting in death when biomarker values are unavailable 
 
 
Type 4a Myocardial infarction related to percutaneous coronary intervention (PCI)  
 
 
Type 4b Myocardial infarction related to stent thrombosis 
 
 
Type 5   Myocardial infarction related to coronary artery bypass  grafting (CABG) 
 
3.  Committee comments (if applicable):  ___________________________________________________ 
      __________________________________________________________________________________ 
      __________________________________________________________________________________ 
      __________________________________________________________________________________ 
      __________________________________________________________________________________ 
 
Form Completed By: ________________________________________________   Date ______________ 
 
 
_______________________________________/_________________________   __________________ 
Signature of Chair, Clinical Events Committee / PRINTED NAME  
 
  Date 
 
 
 
 
 
CSP#588 - REGROUP, Classification of MI, Version 1.2 – October 1, 2013                    Form 20, Page 1 of 1 

Form 21 – Cause of Death  
 
 
SITE NO. 
        SUBJECT ID                             ALPHA CODE                         DATE FORM COMPLETED 
 
 
 
 
 
 
 
 
 
  
 
 
 
Month 
Day            Year 
 
 
FORM 21 – CAUSE OF DEATH BY CLINICAL EVENTS COMMITTEE 
 
 
1.  Date of Death  .................................................................................  
                                                                                                                          Month          Day               Year               
Cause of Death 
a. Specific cause of death (based on review of available medical chart data) 
____________________________________________________________________ 
____________________________________________________________________ 
 
b. Primary cause of death was most likely 
          Cardiac related 
           Not cardiac related 
           Unknown 
c. Detailed information about primary cause of death by category 
            Accident                                        Cerebrovascular 
             Suicide                                           Pulmonary 
             Infection                                        Cancer 
             Cardiovascular                              Other 
 
 
Completed by ___________________________________________________   Date ____________ 
 
 
 
 
 
 
CSP#588 - REGROUP, Cause of Death, Version 1.2 – October 1, 2013                      Form 21, Page 1 of 1 

VA COOPERATIVE STUDY #588 
 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
 
Site Selection Process: Vein Harvester Qualification Policy 
 
1. VA sites with active Cardiac Surgery Programs are contacted with introductory letter 
including executive summary and relevant manuscripts via email. 
 
2. Interested sites provide high-level overview of the sites Cardiac Surgery Service eligibility 
criteria: 
• 
established EVH program >2years,  
• 
sufficient isolated CABG volume to enroll 2-3 subjects/month x3 years,  
• 
willingness to randomize to EVH vs. OVH,  
• 
at least one harvester experience includes > 100 EVH with conversion rate <5%,  
• 
ability to competently provide care for OVH procedure. 
 
3. All potential sites complete CSP #588 Form 15 for each individual harvester who is expected 
to perform the vein harvesting procedure as part of normal daily job duties during the 
course of study participation at the site. The forms are signed by the site Principle 
Investigator (site surgeon investigator) as verification. 
 
4. Each completed form is submitted to and reviewed by the Study Chair’s office.  
 
5. A Subcommittee of the Executive Committee will review each site case by case to determine 
eligibility status and designate each site as one of the following: 
 
A. Site with at least one harvester experienced in BOTH EVH and OVH confirmed by the 
site surgeon investigator => site confirmed as qualified for study participation and 
harvester assigned a code by CSPCC. 
 
B. Site with at least one harvester experienced in EVH but NOT OVH confirmed by the 
site surgeon investigator => site confirmed as qualified for study participation only 
IF a designated harvester for OVH is identified, assigned a code by CSPCC, and MUST 
be immediately available, in addition to the EVH harvester, at time of randomization 
and harvesting (i.e.  the site surgeon investigator). 
 
I. 
Site with NO harvester experienced in EVH and/or incapable of providing OVH 
procedure=> site is INELIGIBLE for study participation at this time regardless of 
interest level or CABG volume. 
Subcommittee Members: Marco Zenati MD, MSc, FETCS; Jerene Bitondo, PA-C; Jennifer Gabany, CRNP 
CSP #588 
RANDOMIZED ENDO-VEIN GRAFT PROSPECTIVE – REGROUP TRIAL  
Version 1.2 Protocol 
October 1, 2013 
 
 
 
 
 
 
 
 
 
 
F-1