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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: Completed NA study, sponsored by Medinol.
NCT01995487 is a NA study that has completed, run by Medinol. The registered enrollment target is 1,919 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (37% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint of TLF at 12 months was defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
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 |
What the finished NCT01995487 record still lists
NCT01995487 is an interventional study that assigns participants to a tested intervention. Its 1,919 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (37% higher).
The record links to 0 conditions, and to 2 interventions - of which BioNIR is the first listed.
NCT01995487 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01995487's enrollment target sits among peer trials
1,919 55th of 2000 higher than 1,946 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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