VEST Venous Graft External Support Pivotal Study

Inclusion Criteria:

1. Signed informed consent, inclusive of release of medical information, and HealthInsurance Portability and Accountability Act (HIPAA) documentation.

2. Age 21 years or older.

3. Planned and scheduled on-pump CABG.

4. Two or more vein grafts to native vessels having at least 75% stenosis andcomparable runoff.

5. IMA graft indicated for the LAD. Additional arterial grafts may be considered basedon practice guidelines.

6. Appropriately sized and accessible target coronary arteries, with a minimum diameterof 1.5 mm and adequate vascular bed (without significant distal stenosis), asassessed by pre-operative cardiac angiography and verified by diameter gaugingintraoperatively.

Exclusion Criteria:

1. Concomitant non-CABG cardiac surgical procedure.

2. Prior cardiac surgery.

3. Emergency CABG surgery.

4. Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcifiedaorta).

5. Calcification at the intended anastomotic sites, as assessed upon opening of thechest and before randomization.

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

7. History of clinical stroke within 3 months prior to randomization.

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

9. Documented or suspected untreated diffuse peripheral vascular disease such as:carotid stenosis or claudication of the extremities.

10. Concomitant life-threatening disease likely to limit life expectancy to less thantwo years.

11. Inability to tolerate or comply with required guideline-based post-operative drugregimen (antiplatelet plus statin) and/or inability to take aspirin.

12. Inability to comply with required follow-ups including angiographic imaging methods (e.g. contrast allergy).

13. Concurrent participation in an interventional (drug or device) trial.