A Clinical Evaluation of AMJ-401
A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan
| Condition(s) | Ischemic Heart Disease (IHD) |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan |
| Who can participate | Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must be able to provide written Informed Consent prior to any study related procedure, per site requirements. 3. Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia, unstable angina, acute myocardial infarction) suitable for elective PCI. 4. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. 5. 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 o |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Abbott Medical Devices |
| Locations | Toyoake, Aichi-ken, Japan; Tokyo, Chiyoda-ku, Japan; Kitakyushu, Fukuoka, Japan; Shiwa-gun, Iwate, Japan; Kamakura, Kanagwa, Japan; Kawasaki, Kanagwa, Japan (+4 more sites) |
| Start date | 2025-12-17 |
| NCT ID | NCT07373353 |
| Official listing | https://clinicaltrials.gov/study/NCT07373353 |