Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A coronary artery bypass graft (CABG) is a surgical procedure used to treat coronary heart disease. In coronary heart disease, the major arteries supplying blood to the heart become narrowed, or blocked, due to the build-up of fatty deposits (plaques). This condition is called atherosclerosis. A CABG is used to improve both blood and oxygen supply to the heart and reduce the risk of a heart attack. It involves taking a blood vessel from elsewhere in the body – usually from the chest, arm or leg – and attaching it above and below the portion of coronary artery that has been affected by atherosclerosis. In this study, we want to compare three different ways to take out a leg vein (referred to as harvesting the vein) for CABG to see which one is the best technique.

Who can participate?
Adults who are at least 18 and undergoing CABG at the University Hospital of South Manchester (UK)

What does the study involve?
Patients are allocated randomly for one of the three vein removal techniques and the removed vein then used for CABG. A small sample of the vein in each case is taken to laboratory for further cell studies. We look at how cells that make up the vein have reacted to the different vein removal techniques used. The patients are also contacted by telephone every 3 months for the first year post-surgery and then again 3 years and 5 years after the operation. On each of these occasions, a member of the research team asks them to complete a questionnaire about their progress.

What are the possible benefits and risks of participating?
Possible postoperative risks include wound infection, wound gapping, pain and serous discharge (weeping) from the wound site. This study will provide data which will guide selection of the best vein harvesting technique in future clinical practice.

Where is the study run from?
Cardiothoracic department and Transplant research laboratory, University Hospital of South Manchester NHS Foundation Trust, Manchester (UK)

When is the study starting and how long is it expected to run for?
January 2011 to January 2015

Who is funding the study?
1. NIHR CAT Clinical Research Fellowship (UK)
2. University Hospital of South Manchester (UK)

Who is the main contact?
Professor Nizar Yonan

Trial website

Contact information



Primary contact

Prof Nizar Yonan


Contact details

Cardiothoracic Consultant Surgeon
1st Floor
CT theatres
Wythenshawe Hospital
SouthMoor Road
South Manchester
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A randomised study comparing Vein Integrity and Clinical Outcomes (VICO) in open vein harvesting and two types of endoscopic vein harvesting for Coronary Artery Bypass Surgery - The VICO trial.



Study hypothesis

1. Is there any difference in[DOE1] vein integrity following vein harvesting with open vein harvesting (OVH), closed-tunnel endoscopic vein harvesting (CT-EVH) and open-tunnel endoscopic vein harvesting (OTEVH)?
2. Are there any differences in clinical outcomes (ie mortality, graft failure, myocardial infection) between OVH, CT-EVH and OT-EVH?
3. Is there any association between[DOE2] vein integrity and clinical outcomes?
4. Are there any differences in patient reported outcomes (ie health-related quality of life and satisfaction) between OVH, CT-EVH and OT-EVH?
5. Are there any differences in cost between these techniques?

Ethics approval

National Research Ethics Committee (NREC); 12/NW/0572

Study design

Single centered randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Coronary artery bypass surgery


Computer block randomisation assigned the patients to undergo an open vein harvesting (control group: n=150), Closed tunnel CO2 endoscopic vein harvesting (n=150) and Open tunnel CO2 endoscopic vein harvesting (n=150). THe assignment number will be concealed in a closed envelope separately for each patient by an independent Statistical team member who are not involved in this study or involved to the research group. The enevelope will be delivered and opened by the surgical team (as late as possible ), once the patient is anaesthetised for the surgery on the operating room.

Control group: Will receive a standard open vein harvesting with a long incision on their donor leg.
Group 1 : Closed tunnel : Will receive a endoscopic vein harvesting(Maquet EVH device) of two or three 2-3 cms cut in their donor leg.
Group 2: Open tunnel : Will receive a endoscopic vein harvesting(Sorin EVH device) of two or three 2-3 cms cut in their donor leg.

All the patients in this study will be donoating 3 cms (1cm x3) of vein samples will be collected from each patient during the surgery and will be send to the laboratory for tissue investigations.

All the patients will be followed up until their discharge from day 1 of their operation. They will be contact on the telephone at 3 month intervals within the first year, and then at 1,3 and 5 years.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Long saphenous vein integrity (as indicated by the level of histological damage)

Secondary outcome measures

1. Post-surgical clinical outcomes, specifically major adverse cardiac events such as reoccurrence of angina, myocardial infarction, vein graft failure, mortality and wound complications.
2. Patient reported outcomes: Generic health related quality of life.
3. Health economic analysis: The primary aim of the economic analysis will be to compare the costs and effects of the three approaches to vein harvesting.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Patients undergoing CABG surgery at the University Hospital of South Manchester
2. Age 18 year or over
3. Who provides written informed consent

Participant type


Age group




Target number of participants

300 patients for initial recruitment and the results will be analysed and discussed in the ethics meeting. If there is a need, the study will be continued until 450 patients recruitment.

Participant exclusion criteria

1. Any patient who refuses or withdraws the consent
2. Patients undergoing emergency surgery or a contra-indication to a technique including varicose vein on the long saphenous vein, small or thin legs and a superficial LSV

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cardiothoracic Consultant Surgeon
South Manchester
United Kingdom

Sponsor information


University Hospital of South Manchester NHS Foundation Trust (UK)

Sponsor details

c/o Mrs Margaret Cooper
Associate Director
Research and Development Office
SouthMoor Road
South Manchester
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

NIHR CAT Clinical Research Fellowship (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

University Hospital of South Manchester (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes