Study of the PAS-Port® Proximal Anastomosis System in Coronary Bypass Surgery

PRE-OPERATIVELY

Inclusion criteria

• Able to give informed consent, able to understand the intent and clinical meaning of the study as well as its implications. Patient is legally competent.
• Assessment that the patient is willing and able to have follow-up visits and examinations
• Age greater than or equal to 50 years and less than 85 years
• Ejection fraction of >30%
• Can tolerate radiographic contrast media
• Requires non-emergent coronary artery bypass with at least two vein bypass grafts intended
• Coronary artery targets intended for bypass index grafts must have >70% native stenosis
• Life expectancy >1 year

Exclusion criteria

• Patient is participating in other clinical trials that would conflict with this protocol
• Unable to meet study requirements (travel, general health)
• Pregnancy
• Previous cardiac surgery
• Requiring preoperative use of an intraaortic balloon pump
• Congestive heart failure / NYHA Class IV
• History of thromboembolic disease requiring ongoing anticoagulation therapy or the presence of a bleeding disorder
• Acute or chronic dialysis
• Creatinine of greater than 200 µmol/L (2.3 mg/dL) in the last 30 days
• Documented acute or suspected systemic infection
• Need for ongoing immunosuppressive therapy
• Recent (less than 2 weeks) history of cerebrovascular accident
• Aspirin allergy or other contraindications to aspirin use

INTRA-OPERATIVELY

Inclusion criteria

• Patient is hemodynamically stable
• Open chest reassessment of the revascularization strategy confirms that two vein bypass grafts are still intended
• Target vessel wall properties that are suitable for performing both a hand-sewn and a PAS-Port anastomosis
• Target vessel is greater than 1.8 mm in diameter at sites where anastomoses are planned
• Target vessel at sites where anastomoses will be placed are free from severe calcifications or severe atheromas
• The length of the vein graft(s) is adequate for both of the planned index graft revascularization strategies
• Vein outside diameter and double wall thickness are between 4 and 6 mm(inclusive) and less than or equal to 1.4 mm, respectively, at the graft site intended for the PAS-Port proximal anastomosis
• The vein(s) is of suitable quality to be used as a bypass graft conduit

Exclusion criteria

-Any of the Intra-operative Inclusion Criteria not met