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RecruitingNCT07373353

A Clinical Evaluation of AMJ-401

AMJ-401 Japan Clinical Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Abbott Medical Devices · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEAMJ-401Patients undergoing percutaneous coronary intervention of one or two de novo native coronary artery lesions with AMJ-401 in separate epicardial coronary vessels

Timeline

Start date
2025-12-17
Primary completion
2026-12-31
Completion
2031-10-31
First posted
2026-01-28
Last updated
2026-04-07

Locations

10 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT07373353. Inclusion in this directory is not an endorsement.