VEST III PMS Clinical Protocol

Inclusion criteria

• Patient scheduled for on-pump CABG on clinical grounds
• Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
• Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
• Ability to give their informed written consent
• Ability and willingness to comply with study follow up requirements
• Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years

Exclusion criteria

• Concomitant non-CABG cardiac procedure
• Prior cardiac surgery
• Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
• Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta)
• Calcification at the intended anastomotic sites, as assessed upon opening of the chest, before randomization
• Severe vein varicosity
• Prior debilitating stroke less than 1 year before surgery
• Severe renal dysfunction (Cr>2.0 mg/dL or >177 μmol/L)
• Women of child bearing age
• Concomitant life-threatening disease likely to limit life expectancy to less than 5 years
• Indication for Warfarin up to time of surgery
• Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.
• inability to take aspirin
• Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
• Inability to comply with required follow-ups including angiographic and/or CT imaging methods.
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study