CompletedNot Applicable

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

Japan104 participantsStarted 2017-01-16

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient with indication for PCI including angina (stable/unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, or recent subacute STEMI. For subacute STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>72 hours prior to enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
. Non-target vessel PCI are allowed prior to enrollment depending on the time interval and conditions as follows:

Exclusion criteria

. Patient is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Target Lesion Failure (TLF)

Timeframe: 12 months

Trial details

NCT IDNCT02828917

SponsorMedinol Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06

Results submitted2020-08-16

View on ClinicalTrials.gov More de Novo or Restenosis Lesions trials