VEST Venous Graft External Support Pivotal Study

Prior treatment

• Concomitant non-CABG cardiac surgical procedure.
• Prior cardiac surgery.
• Emergency CABG surgery.
• History of clinical stroke within 3 months prior to randomization.
• Concomitant life-threatening disease likely to limit life expectancy to less than two years.
• Inability to tolerate or comply with required guideline-based post-operative drug regimen (antiplatelet plus statin) and/or inability to take aspirin.
• Concurrent participation in an interventional (drug or device) trial.

Other illness

• Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
• Inability to comply with required follow-ups including angiographic imaging methods (e.g. contrast allergy).

Lab values

• Severe renal dysfunction (Cr\>2.0 mg/dL).

Other

• 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 and before randomization.
• Severe vein varicosity as assessed after vein harvesting and before randomization.

• Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
• Age 21 years or older.
• Planned and scheduled on-pump CABG.
• Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
• IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
• Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography and verified by diameter gauging intraoperatively.