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Completed

NCT Number: NCT01974492

Comparison of Saphenous Vein Graft Harvested From Upper Versus Lower Leg in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper leg vein harvesting

Procedure

Patients whose saphenous veins are harvested from upper legs.

Lower leg vein harvesting

Procedure

Patients whose saphenous veins are harvested from lower legs.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

A Comparison of Histologic and Immunohistochemical Characteristics Between the Upper and Lower Leg Saphenous Veins Used for Coronary Artery Bypass Grafting

Acronym: COSAVEGUL-1

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 1, 2013
Registry last updated
Jul 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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