A Clinical Evaluation of AMJ-401

Recruiting now · Not applicable

Conditions studied: Ischemic Heart Disease (IHD)

In brief

A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan

Key facts

Study ID

NCT07373353

Run by

Abbott Medical Devices

People needed

50

Starts

2025-12-17

Expected to finish

2031-10-31

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Fujita Health University Hospital — Toyoake, Aichi-ken, Japan (enrolling)
• Mitsui Memorial Hospital — Tokyo, Chiyoda-ku, Japan (enrolling)
• Kokura Memorial Hospital — Kitakyushu, Fukuoka, Japan (enrolling)
• Iwate Medical University Hospital — Shiwa-gun, Iwate, Japan (enrolling)
• Shonan Kamakura General Hospital — Kamakura, Kanagwa, Japan (enrolling)
• Kawasaki-Saiwai Hospital — Kawasaki, Kanagwa, Japan (enrolling)
• Miyazaki Medical Association Hospital — Miyazaki, Miyazaki, Japan (enrolling)
• Kindai University Hospital — Sakai, Osaka, Japan (enrolling)
• Teikyo University Hospital — Itabashi-ku, Tokyo, Japan (enrolling)
• Showa Medical University Hospital — Shinagawa-ku, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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