At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center Study for Evaluating the Safety and Efficacy of the MedJ-01 Ridaforolimus Eluting Coronary Stent System (MedJ-01) In Coronary Stenosis Trial
In Brief
A clinical study evaluating MedJ-01 Ridaforolimus Eluting Coronary Stent System for de Novo or Restenosis Lesions. Completed, enrolled 104 participants across 1 site.
Detailed Summary
MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * A mounted Cobalt Chromium (CoCr) alloy based stent * A Rapid Exchange (RX) Coronary System Delivery System * A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating * Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions. JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient population to show equivalence to the results of the BIONICS Trial.