A Clinical Evaluation of AMJ-401

April 6, 2026 updated by: Abbott Medical Devices

AMJ-401 Japan Clinical Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this clinical investigation is to demonstrate the safety and performance of AMJ-401 Everolimus Eluting Resorbable Scaffold System in the treatment of de novo native coronary artery lesions. Patients undergoing percutaneous coronary intervention of one or two de novo native coronary artery lesions in separate epicardial coronary vessels will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Recruiting
        • Fujita Health University Hospital
        • Contact:
    • Chiyoda-ku
      • Tokyo, Chiyoda-ku, Japan, 1018643
        • Recruiting
        • Mitsui Memorial Hospital
        • Contact:
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8555
        • Recruiting
        • Kokura Memorial Hospital
        • Contact:
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital
        • Contact:
    • Kanagwa
      • Kamakura, Kanagwa, Japan, 247-8533
      • Kawasaki, Kanagwa, Japan, 212-0014
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 880-2102
        • Recruiting
        • Miyazaki Medical Association Hospital
        • Contact:
    • Osaka
      • Sakai, Osaka, Japan, 590-0197
        • Recruiting
        • Kindai University Hospital
        • Contact:
          • Regional Cooperation Division
          • Phone Number: +81-72-288-7222
          • Email: kindai@kindai.jp
    • Tokyo
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Recruiting
        • Teikyo University Hospital
        • Contact:
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Recruiting
        • Showa Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 or heparin.

  6. 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.

  7. 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.
  8. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure.

Exclusion Criteria:

  1. Elective surgery planned within 12 months after the procedure that will require general anesthesia or discontinuing either aspirin or P2Y12 inhibitor.
  2. 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.
  3. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  4. Subject with known diagnosis of ST-elevation myocardial infarction (STEMI) within 72 hours of the index procedure.
  5. 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.
  6. Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to their arrhythmia
  7. 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).
  8. The target vessel was treated by PCI within 12 months prior to index procedure.
  9. 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.
  10. Subject requires future staged PCI either in target or non-target vessels.
  11. Subject has a malignancy that is not in remission.
  12. 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.
  13. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  14. Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
  15. Subject is receiving or will require chronic anticoagulation therapy (e.g., warfarin).
  16. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
  17. Subject has documented or suspected cirrhosis of Child-Pugh ≥ Class B.

  18. Subject has known renal insufficiency:

    • Dialysis at the time of screening or
    • An estimated GFR < 30 ml/min/1.73m2

  19. 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
  20. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
  21. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion via any vessel.
  22. Subject has life expectancy < 3 years.
  23. 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.
  24. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  25. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention/Treatment
Device: AMJ-401
Patients undergoing percutaneous coronary intervention of one or two de novo native coronary artery lesions with AMJ-401 in separate epicardial coronary vessels

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acute Strut Fracture
Time Frame: 6 months
Acute strut fracture is assessed on a per-subject basis per final post-procedure OCT.
6 months
Strut Coverage
Time Frame: 6 months
Strut coverage is assessed at 6-month OCT follow-up exam as the rate of uncovered struts on a per strut basis.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10615

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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