A Clinical Evaluation of AMJ-401

NCT07373353 | Recruiting

• 1 other identifier: 10615
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Heart Disease (IHD)

Outcome Measures

Primary Outcomes (2)

• Acute Strut Fracture

  Acute strut fracture is assessed on a per-subject basis per final post-procedure OCT.

  6 months

• Strut Coverage

  Strut coverage is assessed at 6-month OCT follow-up exam as the rate of uncovered struts on a per strut basis.

  6 months

Study Arms (1)

Intervention/Treatment

EXPERIMENTAL

Device: AMJ-401

Interventions

AMJ-401 DEVICE

Patients undergoing percutaneous coronary intervention of one or two de novo native coronary artery lesions with AMJ-401 in separate epicardial coronary vessels

Intervention/Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Mitsui Memorial Hospital

Tokyo, Chiyoda-ku, 1018643, Japan

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 28, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2031
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

JP (1)