What is AMJ-401 studying for ischemic heart disease?

AMJ-401 is being studied to evaluate its safety and performance in treating new coronary artery lesions in patients with ischemic heart disease. The research focuses on how well the device works during and after a procedure called percutaneous coronary intervention. Abbott Medical Devices is leading this clinical trial to better understand this treatment option.

Who may be eligible for this ischemic heart disease clinical trial?

Adults aged 18 or older with ischemic heart disease needing elective PCI may be eligible. Participants must be able to take dual antiplatelet therapy for at least 12 months and not be pregnant or breastfeeding if female. People with recent heart attacks or certain heart conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this ischemic heart disease clinical trial?

Study-related care, including the device and all trial visits, is provided at no cost. However, personal travel or other expenses to participate may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07373353

Clinical Study of AMJ-401 Device for Treating Coronary Artery Lesions in Adults with Ischemic Heart Disease in Japan

Led by Abbott Medical Devices · Updated on 2026-04-07

Participants Needed

Research Sites

252 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and performance of the AMJ-401 Everolimus Eluting Resorbable Scaffold System in treating patients with ischemic heart disease in Japan. This study focuses on individuals undergoing percutaneous coronary intervention PCI for one or two new native coronary artery lesions. The investigation aims to assess how well AMJ-401 works in this setting and its safety profile. Participants will receive treatment with the AMJ-401 device during PCI of one or two new native coronary artery lesions located in separate epicardial coronary vessels. The study does not include a comparison group and involves the use of this device as the experimental intervention. The treatment is delivered during the PCI procedure, and the study evaluates outcomes related to the devices performance over time. During the study, participants will be monitored through clinical evaluations, including imaging and assessments of the treated arteries. The primary outcomes measured at six months include the occurrence of acute strut fractures and the coverage of the scaffold struts. Safety and performance will be observed throughout the follow-up period, which extends up to the study completion date in October 2031.

CONDITIONS

Brief Title

A Clinical Evaluation of AMJ-401

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

At least 18 years of age
Able to provide written informed consent
Evidence of myocardial ischemia suitable for elective PCI
Acceptable candidate for coronary artery bypass graft surgery
Able to take dual antiplatelet therapy for at least 12 months post-procedure
No known allergic reaction or contraindication to aspirin, clopidogrel, prasugrel, ticagrelor, ticlopidine, or heparin
Female participants of childbearing potential must not be pregnant and must have a negative pregnancy test within 7 days prior to procedure
Female participants must not be breastfeeding and agree not to breastfeed for at least 12 months post-procedure
Agree not to participate in other investigational or invasive clinical studies for 13 months post-procedure

You will not qualify if you...

Elective surgery planned within 12 months that requires general anesthesia or stopping aspirin or P2Y12 inhibitors
Known hypersensitivity or contraindication to device materials not manageable by pre-medication
Known contrast sensitivity not manageable by pre-medication
STEMI diagnosis within 72 hours prior to procedure
Currently experiencing clinical symptoms of new acute myocardial infarction
Unstable cardiac arrhythmia likely to cause hemodynamic instability
Left ventricular ejection fraction less than 30%
Target vessel treated by PCI within 12 months prior to procedure
Requires future staged PCI in target or non-target vessels
Active malignancy not in remission
Receiving immunosuppressant therapy or life-threatening autoimmune disease
Solid organ transplant recipient or awaiting transplant
Prior or planned radiotherapy to coronary artery or chest
Requires chronic anticoagulation therapy
Platelet count below 100,000 or above 700,000 cells/mm3
Documented or suspected cirrhosis Child-Pugh Class B or higher
Renal insufficiency requiring dialysis or estimated GFR below 30 ml/min/1.73m2
High risk of bleeding or history of significant bleeding events
Cerebrovascular accident or TIA within past six months
Extensive peripheral vascular disease preventing safe sheath insertion
Life expectancy less than 3 years
Unable to comply with study requirements or unsuitable as judged by investigator
Currently participating in another clinical trial without completed primary endpoint
Potential undue influence affecting willingness to volunteer

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Clinical Study of AMJ-401 Device for Treating Coronary Artery Lesions in Adults with Ischemic Heart Disease in Japan

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria