A Clinical Evaluation of AMJ-401

Exclusion Criteria33

• Elective surgery planned within 12 months after the procedure that will require general anesthesia or discontinuing either aspirin or P2Y12 inhibitor.
• Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, PLLA, PDLLA, platinum, lactic acid, and lactide) that cannot be adequately pre-medicated.
• Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
• Subject with known diagnosis of ST-elevation myocardial infarction (STEMI) within 72 hours of the index procedure.
• The subject is currently experiencing clinical symptoms consistent with new onset acute myocardial infarction (AMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
• Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to their arrhythmia
• Subject has a known left ventricular ejection fraction (LVEF) \< 30% (LVEF may be obtained at the time of the index procedure prior to subject registration if the value is unknown and the site Investigator believes it is necessary).
• The target vessel was treated by PCI within 12 months prior to index procedure.
• Prior PCI within the non-target vessel is acceptable if performed anytime \> 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 life-threatening immunosuppressive or life-threatening 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., warfarin).
• Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3.
• Subject has documented or suspected cirrhosis of Child-Pugh ≥ Class B.
• Subject has known renal insufficiency:
• Dialysis at the time of screening or
• An estimated GFR \< 30 ml/min/1.73m2
• Subject has a high risk of bleeding, or;
• Subject has a history of bleeding diathesis or coagulopathy.
• Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
• Subject has prior intracranial bleed (including severe permanent neurologic deficit that seems to be caused by previous intracranial bleeding).
• Subject has known intracranial pathology that may cause intracranial bleeding per investigator assessment (e.g., untreated aneurysm greater than 5 mm, arteriovenous malformation)
• Subject will refuse blood transfusions.
• Subject is receiving antiplatelet medication other than aspirin or P2Y12 inhibitor for the treatment of another condition and cannot discontinue them
• 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 via any vessel.
• Subject has life expectancy \< 3 years.
• Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., subordinate hospital staff or sponsor staff).