Comparison · NCT01995487-deaths
BioNIR vs Resolute: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. BioNIR vs Resolute: deaths from any cause. Trial comparisons, record NCT01995487-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01995487-deaths
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00522 | 0.00223 | 0.0122 | wilson | |
| Risk in group 2 | 0.00208 | 0.000571 | 0.00756 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00314 | -0.0031 | 0.0102 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.51 | 0.488 | 12.9 | log | |
| Odds ratio, group 1 over group 2 | 2.52 | 0.487 | 13 | log | |
| Number needed to harm, for one more death from any cause on BioNIR than on Resolute | 319 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | BioNIR | Subjects received The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising:~* Stent - a mounted Cobalt Chromium (CoCr) alloy based stent~* Delivery System - Rapid Exchange (RX) Coronary System~* Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®~* Ridaforolimus drug - CAS Registry Number: 572924-54-0~The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent).~BioNIR: drug-eluting stent | 5 | 958 | EG000 |
| Group 2 | Resolute | Subjects received The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems:~1. Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent~2. Delivery system (Rapid Exchange \[RX\] Coronary System)~3. Polymer system~4. Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area.~Resolute: drug-eluting stent | 2 | 961 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Source ClinicalTrials.gov
Trial
- Title
- Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
- NCT number
- NCT01995487
- Phases
- NA
- Conditions
- Coronary Artery Stenosis
- Interventions
- BioNIR, Resolute
- Lead sponsor
- Medinol Ltd.
- Results first posted
- 2021-02-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01995487?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01995487-deaths