Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-01-01 @ 2:43 PM
Study NCT ID:
NCT01974492
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2013-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSAVEGUL-1
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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: