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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Ki-Bong Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01974492
First received: October 26, 2013
Last updated: November 4, 2013
Last verified: November 2013

October 26, 2013
November 4, 2013
October 2013
February 2014   (final data collection date for primary outcome measure)
Endothelial preservation of saphenous vein graft [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Endothelial preservation of saphenous vein graft [ Time Frame: After graft harvesting, before target vessel anastomosis ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01974492 on ClinicalTrials.gov Archive Site
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Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in Coronary Artery Bypass Grafting
A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Triple Vessel Disease
  • Unstable Angina
  • Stable Angina
  • Myocardial Infarction
  • Procedure: Upper leg vein harvesting
    Patients whose saphenous veins are harvested from upper legs.
  • Procedure: Lower leg vein harvesting
    Patients whose saphenous veins are harvested from lower legs.
  • Active Comparator: Upper leg vein
    Upper leg vein harvesting
    Intervention: Procedure: Upper leg vein harvesting
  • Active Comparator: Lower leg vein
    Lower leg vein harvesting
    Intervention: Procedure: Lower leg vein harvesting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
September 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact: Hyoung Woo Chang, M.D. +82-10-2709-5694 sspenser@chol.com
Contact: Ki-Bong Kim, M.D., Ph.D. +82-10-5326-3482 kimkb@snu.ac.kr
Korea, Republic of
 
NCT01974492
SNUHTS_KBKim_Saphenous
Yes
Ki-Bong Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Ki-Bong Kim, M.D., Ph.D. Seoul National University Hospital
Seoul National University Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP