AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population

Inclusion Criteria

• Subject must be at least 20 years of age.
• Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
• Female subject of childbearing potential must not be pregnant* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.
• Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
• Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
• Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure

Exclusion Criteria

• Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
• Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
• Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
• Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
• The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
• Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (CK-MB) have not returned to within normal limits at the time of index procedure.
• Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
• Subject has a known left ventricular ejection fraction (LVEF) 30 days before the index procedure or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
• Subject requires future staged PCI either in target or non target vessels.
• Subject has a malignancy that is not in remission.
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
• Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
• Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
• Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
• Subject has a platelet count 700, 000 cells/mm3.
• Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
• Subject has known renal insufficiency;
• Dialysis at the time of screening.
• An estimated Glomerular filtration rate (GFR) 5 mm, arteriovenous malformation)
• Subject will refuse blood transfusions
• Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
• Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
• Subject has lif