Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting (COSAVEGUL-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01974492|
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : July 4, 2016
|Condition or disease||Intervention/treatment|
|Triple Vessel Disease Unstable Angina Stable Angina Myocardial Infarction||Procedure: Upper leg vein harvesting Procedure: Lower leg vein harvesting|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting|
|Study Start Date :||October 2013|
|Primary Completion Date :||April 2015|
|Study Completion Date :||June 2016|
Active Comparator: Upper leg vein
Upper leg vein harvesting
Procedure: Upper leg vein harvesting
Patients whose saphenous veins are harvested from upper legs.
Active Comparator: Lower leg vein
Lower leg vein harvesting
Procedure: Lower leg vein harvesting
Patients whose saphenous veins are harvested from lower legs.
- Endothelial preservation of saphenous vein graft [ Time Frame: 1 year ]Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974492
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Ki-Bong Kim, M.D., Ph.D.||Seoul National University Hospital|