AMJ-401 Japan Clinical Trial
A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan
• Subject must be at least 18 years of age.
• Subject or a legally authorized representative must be able to provide written Informed Consent prior to any study related procedure, per site requirements.
• Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, acute myocardial infarction) suitable for elective PCI.
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Subject must be able to take dual antiplatelet therapy (DAPT) for minimum of 12 months following the index procedure and anticoagulants prior/during the index procedure, and the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine or heparin.
• Female subjects of childbearing potential must not be pregnant\* at screening and do not plan pregnancy for at least 12 months following the index procedure.
• \* Female subjects of child-bearing potential must have a negative pregnancy result within 7 days prior to the index procedure.
• Female subjects must not be breast-feeding at the time of the screening visit and will not be breast-feeding for at least 12 months 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.