CompletedNot Applicable

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

United States, Belgium, Canada1,919 participantsStarted 2014-01

Plain-language summary

The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is non-inferior to the Resolute for the secondary endpoint of angiographic in-stent late loss at 13 months; and that it is more cost-effective.

Who can participate

Age range

18 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/silent ischemia/NSTEMI/recent STEMI * Non-target vessel PCI allowed prior to randomization depending on time interval and certain conditions * Patient/legal guardian willing \& able to provide informed written consent \& comply with follow-up visits \& testing schedule * Target lesion(s) must be located in native coronary artery/bypass graft conduit w/visually estimated diameter ≥2.5mm to ≤4.25mm. * Complex lesions allowed, including calcified, presence of thrombus, CTO, bifurcation (except as per exclusion criteria #30), ostial RCA, tortuous, bare metal stent restenotic, protected left main, and saphenous vein graft Exclusion Criteria: * STEMI within 24 hours of init. time of presentation to first treating hospital, or in whom enzyme levels (either CK-MB or Troponin) have not peaked * PCI within 24 hours preceding baseline procedure * Non-target lesion PCI in target vessel within 12 months of baseline procedure * History of stent thrombosis * Cardiogenic shock (persistent hypotension \[systolic blood pressure \<90mm/Hg for MT 30 min\] or requiring pressors/hemodynamic support, including IABP) * Subject is intubated * Known LVEF \<30% * Relative/absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject indicated for chronic oral anticoagulant treatment) * Calculated creatinine clearance \<30 mL/min per Cockcroft-Gault equation (\<40mL/min for subject…

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 IDNCT01995487

SponsorMedinol Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08-28

Results submitted2020-08-12

View on ClinicalTrials.gov More Coronary Artery Stenosis trials