← Back to Clinical Trials
Recruiting NCT07373353

A Clinical Evaluation of AMJ-401

Trial Parameters

Condition Ischemic Heart Disease (IHD)
Sponsor Abbott Medical Devices
Study Type INTERVENTIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-12-17
Completion 2026-12-31
Interventions
AMJ-401

Brief Summary

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

Eligibility Criteria

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-

Related Trials