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Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

NCT01995487 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1919

Last updated 2023-10-16

Study results available
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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.

Conditions

  • Coronary Artery Stenosis

Interventions

DEVICE

BioNIR

drug-eluting stent

DEVICE

Resolute

drug-eluting stent

Sponsors & Collaborators

  • Medinol Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-08-28
Completion
2020-11-30

Countries

  • United States
  • Belgium
  • Canada
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain

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 NCT01995487 on ClinicalTrials.gov