Optical Coherence Tomography of the Saphenous Vein Graft

Exclusion Criteria21

• STEMI ≤24 hours from the onset of ischemic symptoms
• Creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) and not on dialysis.
• Hypotension, shock or need for mechanical support or intravenous vasopressors at the time that the patient would be undergoing the index procedure.
• CHF (Killip class \>2 or NYHA class \>3)
• LVEF \<30% by the most recent imaging test within 6 months prior to procedure. If no LVEF test result within 6 months is available, it must be assessed by echocardiography, multiple gated acquisition (MUGA), magnetic resonance imaging (MRI), ventriculography (LV gram) or other method.
• Unstable ventricular arrhythmias
• Concomitant multi-valve surgery or major aortic root surgery.
• Planned non-cardiac surgery within 24 months after the index procedure
• Prior CABG
• Any planned PCI within any target vessel(s) within 24 months.
• Subject has known hypersensitivity or contraindication to any of the study drugs (including aspirin, all P2Y12 inhibitors).
• Subject has received a heart transplant.
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.).
• Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
• Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
• Subject has a history of bleeding diathesis or coagulopathy.
• Subject has life expectancy \<2 years for any non-cardiac cause.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
• Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
• \. Severe conduit tortuosity of venous conduit (e.g., with varicosities) such that it is unlikely that the OCT catheter can be delivered without vascular damage.