Assessing Vein Graft Properties Between Conventional & No-Touch Harvesting Technique - (PATENT SVG)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare saphenous veins harvested using the atraumatic
      pedicled ("no-touch") technique to saphenous veins harvested using the conventional open
      technique in patients undergoing isolated coronary artery bypass surgery. Investigators will
      compare the biological structure of the saphenous veins harvested using these two techniques.
      There is some evidence that saphenous veins harvested using the "no-touch" technique may
      allow for better patency up to 8 years following bypass surgery. We may be able to detect
      early differences in vascular structure, observed at the time of conduit harvest.
    

Detailed description: 
      Atherosclerosis is a complex, multifactorial inflammatory disease, which is initiated largely
      in areas of endothelial injury, secondary to biomechanical disturbances, or systemic factors
      such as lipoprotein disturbances, hypertension, diabetes, and smoking (the response to injury
      hypothesis). Accumulating data indicate that structural and/or functional alterations in
      endothelial integrity play a primordial role in the development of atherosclerosis via
      promoting aberrant interactions between modified lipoproteins, monocyte-derived macrophages,
      T cells and normal cellular elements of the arterial wall inciting early plaque formation. As
      such, strategies, either pharmacological or mechanical in nature which reduce and/or restore
      endothelial homeostasis remain an important cornerstone to limit atherosclerosis.

      Investigators hypothesize that saphenous veins harvested using the atraumatic pedicled
      ("no-touch") technique from patients undergoing isolated coronary artery bypass surgery will
      exhibit superior indices of vasomotor structure compared to veins harvested using the
      conventional open technique. We anticipate that leg healing will not be significantly altered
      using the "no-touch" technique.

      Eligible patients will have two SVG segments harvested, one from each lower leg. One leg will
      have the SVG harvested in the conventional fashion and the contralateral leg will have the
      SVG harvested using the "no touch" technique. This will be determined by block randomization
      revealed at the time of skin incision. For patients with very small lower leg saphenous
      veins, the surgical protocol would be to then use the thigh segment instead. Patients will
      have Duplex scans to evaluate saphenous veins pre-operatively.
    

Intervention name(s): Coronary Artery Bypass Graft Surgery; Conventional open SVG harvesting
Intervention type(s): Procedure; Procedure
Intervention description(s): Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery; SVG harvested using conventional open technique and manually distended with crystalloid solution
Other intervention name(s): Pedicled "no-touch" saphenous vein graft harvesting; Conventional open saphenous vein graft harvesting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Saphenous vein graft patency; Coronary artery bypass surgery; Coronary artery disease