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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,919 participants |
| Start Date | 2014-01 |
| Est. Completion | 2020-11-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗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.
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