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Completed Not applicable Interventional Results available

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

ClinicalTrials.gov ID: NCT01995487

Public ClinicalTrials.gov record NCT01995487. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01995487
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Medinol Ltd.
Industry
Enrollment
1,919 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2013
Primary completion
Aug 27, 2016
Completion
Nov 29, 2020
Last update posted
Oct 15, 2023

2014 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Piedmont Healthcare Atlanta Georgia 30309

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01995487, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 15, 2023 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01995487 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →