At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,919 enrolled
Drug / intervention
BioNIR +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial
In Brief
A clinical study evaluating BioNIR and Resolute for Coronary Artery Stenosis. Completed, enrolled 1,919 participants across 8 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Stenosis
CountriesBelgium, Canada, Israel, Italy, Netherlands, Poland, Spain, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 2013
Enrollment StartJan 2014
Primary CompletionAug 2016
Study CompletionNov 2020
TodayJul 2026
First PostedNov 26, 2013
Enrollment StartJan 1, 2014
Primary CompletionAug 28, 2016
Study CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.6 years ago
Interventions
BioNIRdevice
drug-eluting stent
Resolutedevice
drug-eluting stent