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Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting (COSAVEGUL-1)

Primary Purpose

Triple Vessel Disease, Unstable Angina, Stable Angina

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Upper leg vein harvesting
Lower leg vein harvesting
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Vessel Disease focused on measuring saphenous vein graft, composite graft, coronary artery bypass grafting, graft remodeling

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with multivessel disease who were planned to undergo off-pump coronary artery bypass grafting
  • Patients whose left internal thoracic arteries can be used, and whose saphenous vein grafts will be Y-anastomosed to left internal thoracic arteries.
  • Patients whose saphenous vein grafts can be harvested from both upper and lower legs.

Exclusion Criteria:

  • Patients with overt heart failure symptoms
  • Patients with intractable ventricular arrhythmia
  • Patients with history of cancer or malignancy
  • Patients with coagulation or other hematologic disorder
  • Patients who needs concomitant cardiac procedures

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Upper leg vein

Lower leg vein

Arm Description

Upper leg vein harvesting

Lower leg vein harvesting

Outcomes

Primary Outcome Measures

Endothelial preservation of saphenous vein graft
Participants will be followed for the duration of hospital stay, an expected average of 1 week.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2013
Last Updated
June 30, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01974492
Brief Title
Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting
Acronym
COSAVEGUL-1
Official Title
A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In coronary artery bypass grafting, saphenous veins are widely used as a composite grafts that are Y-anastomosed to in-situ left internal thoracic artery. Based on our observation that remodeling of saphenous vein graft differs between those harvested from upper leg vein and lower leg, this study aims to compare histologic and immunohistochemical findings between saphenous vein grafts harvested from upper leg and lower leg.
Detailed Description
Inclusion criteria: Patients aged from 40 to 75 years with triple vessel disease Patients who are eligible for the use of left internal thoracic artery as an in situ primary conduit Operation plan: saphenous vein graft will be Y-anastomosed to left internal thoracic artery. Patients whose saphenous vein grafts can be harvested from both upper legs and lower legs Patients who are eligible for off-pump coronary artery bypass grafting Patients who agreed with the participation in the research based on thorough explanation. Patients will be randomly assigned to upper leg vein (ULV) group and lower leg vein (LLV) group immediately after anesthetic induction. Pieces of residual saphenous vein graft will be sent for histologic and immunohistochemical examination for the evaluation of endothelial cell preservation and the expression of matrix proteins.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Vessel Disease, Unstable Angina, Stable Angina, Myocardial Infarction
Keywords
saphenous vein graft, composite graft, coronary artery bypass grafting, graft remodeling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upper leg vein
Arm Type
Active Comparator
Arm Description
Upper leg vein harvesting
Arm Title
Lower leg vein
Arm Type
Active Comparator
Arm Description
Lower leg vein harvesting
Intervention Type
Procedure
Intervention Name(s)
Upper leg vein harvesting
Intervention Description
Patients whose saphenous veins are harvested from upper legs.
Intervention Type
Procedure
Intervention Name(s)
Lower leg vein harvesting
Intervention Description
Patients whose saphenous veins are harvested from lower legs.
Primary Outcome Measure Information:
Title
Endothelial preservation of saphenous vein graft
Description
Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with multivessel disease who were planned to undergo off-pump coronary artery bypass grafting Patients whose left internal thoracic arteries can be used, and whose saphenous vein grafts will be Y-anastomosed to left internal thoracic arteries. Patients whose saphenous vein grafts can be harvested from both upper and lower legs. Exclusion Criteria: Patients with overt heart failure symptoms Patients with intractable ventricular arrhythmia Patients with history of cancer or malignancy Patients with coagulation or other hematologic disorder Patients who needs concomitant cardiac procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Bong Kim, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting

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