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MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)

NCT02828917 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-10-16

Study results available
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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.

Conditions

  • de Novo or Restenosis Lesions

Interventions

DEVICE

MedJ-01 Ridaforolimus Eluting Coronary Stent System

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Principal Investigators

  • Shigeru Saito, MD · Shonan Kamakura General Hospital

  • Seiji Yamazaki, MD · Sapporo Higashi Tokushukai Hospital

  • Atsuo Namiki, MD · Kanto Rosai Hospital

  • Yoshisato Shibata, MD · Miyazaki Medical Association Hospital

  • Satoru Otsuji, MD · Higashi Takarazuka Satoh Hospital

  • Shigeu Nakamura, MD · Kyoto Katsura Hospital

  • Akihiko Takahashi, MD · Takahashi Hospital

  • Tomohiro Kawasaki, MD · Shin Koga Hospital

  • Yasuhiro Makita, MD · Hospital Hakodate Hokkaido

  • Takeshi Serikawa, MD · Saiseikai Fukuoka General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2018-06-30
Completion
2022-08-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828917 on ClinicalTrials.gov