Actively Recruiting
A Clinical Evaluation of AMJ-401
Led by Abbott Medical Devices · Updated on 2026-04-07
50
Participants Needed
10
Research Sites
306 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Clinical Evaluation of AMJ-401 in the Treatment of Subjects with Ischemic Heart Disease in Japan
CONDITIONS
Official Title
A Clinical Evaluation of AMJ-401
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must be at least 18 years of age.
- Subject or legally authorized representative must provide written informed consent before any study procedures.
- Subject must have evidence of myocardial ischemia suitable for elective percutaneous coronary intervention (PCI).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must be able to take dual antiplatelet therapy for a minimum of 12 months after the procedure and have no known allergies or contraindications to specified antiplatelet or anticoagulant medications.
- Female subjects of childbearing potential must not be pregnant at screening and must not plan pregnancy for at least 12 months following the procedure.
- Female subjects must have a negative pregnancy test within 7 days prior to the procedure.
- Female subjects must not be breastfeeding at screening and for at least 12 months after the procedure.
- Subject agrees not to participate in any other investigational or invasive clinical study for 13 months following the procedure.
You will not qualify if you...
- Elective surgery planned within 12 months after the procedure requiring general anesthesia or stopping aspirin or P2Y12 inhibitor.
- Known hypersensitivity or contraindication to device materials or degradants that cannot be pre-medicated.
- Known contrast sensitivity that cannot be pre-medicated.
- Diagnosis of ST-elevation myocardial infarction (STEMI) within 72 hours before the procedure.
- Current symptoms of new acute myocardial infarction.
- Unstable cardiac arrhythmia likely to become hemodynamically unstable.
- Left ventricular ejection fraction less than 30%.
- Target vessel treated by PCI within 12 months before the procedure.
- Need for future staged PCI in target or non-target vessels.
- Active malignancy not in remission.
- Receiving immunosuppressant therapy or having life-threatening immunosuppressive or autoimmune disease.
- Prior or planned solid organ transplant.
- Previous or planned radiotherapy to coronary artery or chest area.
- Receiving or needing chronic anticoagulation therapy.
- Platelet count less than 100,000 or greater than 700,000 cells/mm3.
- Documented or suspected cirrhosis of Child-Pugh Class B or higher.
- Renal insufficiency requiring dialysis or estimated GFR less than 30 ml/min/1.73m2.
- High risk of bleeding or history of significant bleeding conditions.
- Cerebrovascular accident or transient ischemic attack within past six months.
- Extensive peripheral vascular disease preventing safe sheath insertion.
- Life expectancy less than 3 years.
- Unable to comply with study protocol or deemed unsuitable by investigator.
- Currently participating in another clinical trial that has not completed its primary endpoint.
- Willingness to volunteer influenced by expectation of benefits or retaliation risk.
AI-Screening
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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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