Actively Recruiting
AMJ-401 Japan Clinical Trial for Ischemic Heart Disease Evaluating Everolimus Eluting Resorbable Scaffold System
Led by Abbott Medical Devices · Updated on 2026-04-07
50
Participants Needed
10
Research Sites
252 weeks
Total Duration
On this page
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 device's 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
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
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo percutaneous coronary intervention with the AMJ-401 Everolimus Eluting Resorbable Scaffold System to treat coronary artery lesions.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for safety and performance outcomes including acute strut fracture and strut coverage over 6 months after the procedure.
Approximately 6 post-operative visits
Trial Site Locations
Total: 10 locations
1
Fujita Health University Hospital
Toyoake, Aichi-ken, Japan, 470-1192
Actively Recruiting
2
Mitsui Memorial Hospital
Tokyo, Chiyoda-ku, Japan, 1018643
Actively Recruiting
3
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Actively Recruiting
4
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan, 028-3695
Actively Recruiting
5
Shonan Kamakura General Hospital
Kamakura, Kanagwa, Japan, 247-8533
Actively Recruiting
6
Kawasaki-Saiwai Hospital
Kawasaki, Kanagwa, Japan, 212-0014
Actively Recruiting
7
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, Japan, 880-2102
Actively Recruiting
8
Kindai University Hospital
Sakai, Osaka, Japan, 590-0197
Actively Recruiting
9
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan, 173-8606
Actively Recruiting
10
Showa Medical University Hospital
Shinagawa-ku, Tokyo, Japan, 142-8666
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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