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A Clinical Evaluation of AMJ-401 | Clinical Trials | Clareo Health

RECRUITINGNA

A Clinical Evaluation of AMJ-401

AMJ-401 Japan Clinical Trial

NCT07373353•Abbott Medical Devices

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+23 more criteria

Locations (1)

Mitsui Memorial Hospital

Tokyo, Chiyoda-ku, Japan

Key Dates

Start Date

December 17, 2025

Primary Completion Date

December 31, 2026

Completion Date

October 31, 2031

Last Updated

January 28, 2026

Enrollment

ESTIMATED participants

Conditions

Ischemic Heart Disease (IHD)

Interventions

AMJ-401

DEVICE

CMR Prognostic Markers in Ischemic Heart Disease

NCT07351825

Ischemic Heart Disease (IHD)Myocardial Infarction (MI)

View study

ACTIVE_NOT_RECRUITING

Verona Coronary Physiology Interventional Registry

NCT07186582

Coronary Artery DiseaseIschemic Heart Disease (IHD)+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Evaluation of AMJ-401

Inclusion Criteria

Exclusion Criteria

CMR Prognostic Markers in Ischemic Heart Disease

Verona Coronary Physiology Interventional Registry

XTR003 PET Radiotracer for the Detection of Viable Myocardium