The eMESH 1 Feasibility Study

• MACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG).
• SVG patency determined by angiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  Angiographic patency rate of the enrolled grafts defined as < 50% stenosis.
• Technical success implanting eSVS Mesh [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
  Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG.

• MACCE and mediastinitis [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months.
• SVG patency determined by angiography [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  Angiographic patency rate of the enrolled grafts defined as < 75%.
• Plaque burden [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study).

Multi-center, randomized study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. Each study subject will receive a SVG without Mesh (control) and a SVG with Mesh (treatment). The subject will be used as their own control.

• Device: eSVS Mesh treated saphenous vein graft
  During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
• Other: Control saphenous vein graft
  During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.

• Active Comparator: eSVS Mesh treated saphenous vein graft
  Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
  Intervention: Device: eSVS Mesh treated saphenous vein graft
• Sham Comparator: Control saphenous vein graft
  Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.
  Intervention: Other: Control saphenous vein graft

Inclusion Criteria:

• Requires CABG surgery with a SVG to the right coronary artery (RCA) system AND the left circumflex artery (LCX) system with a ≥ 70% stenosis in each of the two systems.
• Medial sternotomy with cardiopulmonary bypass (CPB) during surgery.
• Both saphenous vein graft length are adequate for planned intervention, vein outer diameter is between 3.6 mm and 7.0 mm and double wall thickness less than 1.4 mm.
• Agreement to post-procedure follow-up contact and testing (including follow-up coronary angiogram).

Exclusion Criteria:

• Concomitant non-CABG cardiac procedure.
• Prior cardiac surgery (does not include percutaneous procedures).
• Cerebrovascular or transient ischemia attack within 30 days of the CABG procedure.
• Age > 80 years.
• Left ventricular ejection fraction ≤ 35%.
• Creatinine > 133 μmol/L (1.5 mg/dL) prior to CABG procedure or on chronic dialysis.
• STEMI within 7 days or total CK > 2 times the upper limit of normal prior to the CABG procedure.
• Both enrolled grafts will feed non-viable myocardial territory.
• Diffuse atherosclerotic disease (> 70%) distal to either of the enrolled target coronary arteries.
• By visual estimate, the target coronary artery diameter of both the right coronary system and left circumflex system must be within 1.5mm of each other.
• Planned endarterectomy of the target coronary artery.