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NCT01995487 · ClinicalTrials.gov registry record · NA

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

A NA study, sponsored by Medinol.

Completed
Registry status
NA
Development phase
1,919
Enrollment target

NCT01995487 is a NA study that has completed, run by Medinol. The registered enrollment target is 1,919 participants.

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The verdict

NCT01995487, a NA study, has completed, sponsored by Medinol.

COMPLETED
Registry status
NA
Development phase
1,919 participants
Enrollment target

Study 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.

Interventions

  • DEVICE BioNIR
  • DEVICE Resolute

Trial Details

FieldValue
Enrollment Target 1,919 participants
Start Date 2014-01
Est. Completion 2020-11-30
Phase NA

Sponsor

Medinol

4 total trials

What the Registry Record Tells You About NCT01995487

The ClinicalTrials.gov registry entry for NCT01995487 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,919 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medinol, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which BioNIR is the first listed.

NCT01995487 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01995487 about?

NCT01995487 is a clinical study titled "Study of BioNIR Drug Eluting Stent System in Coronary Stenosis". 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-ste...

What is the current status of trial NCT01995487?

This trial is currently completed. It is a NA study. The enrollment target is 1,919 participants. The study started on 2014-01. Estimated completion is 2020-11-30.

What interventions are being tested in trial NCT01995487?

The interventions under investigation include: BioNIR (DEVICE), Resolute (DEVICE).

Who is sponsoring clinical trial NCT01995487?

This trial is sponsored by Medinol, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.