Trial · NCT01995487

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

NCT01995487, Not applicable, Completed, Medinol Ltd.; results first posted 2021-02-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of BioNIR Drug Eluting Stent System in Coronary Stenosis. Trials, record NCT01995487. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01995487

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
NCT number: NCT01995487
Status: Completed
Phases: Not applicable
Enrollment: 1,919 participants, actual
Lead sponsor: Medinol Ltd.
Conditions: Coronary Artery Stenosis
Interventions: BioNIR, Resolute
First posted: 2013-11-26
Last updated: 2023-10-16
Results first posted: 2021-02-25

Source ClinicalTrials.gov

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Target Lesion Failure (TLF)	12 months	The primary endpoint of TLF at 12 months was defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
Secondary	Device Success	Determined at time of baseline procedure	Clinical: Acute secondary endpoint determined at time of baseline procedure
Secondary	TLF	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical secondary endpoint to be evaluated at 30 days, 6 months, and 2, 3, 4 and 5 years, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR
Secondary	Major Adverse Cardiac Events	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical: MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR
Secondary	Target Vessel Failure	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical: TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR
Secondary	All Cause Mortality	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical: The number of patients who die from all causes
Secondary	Cardiac Death	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical: The number of patients who die of cardiac-related causes
Secondary	Myocardial Infarction	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical: The number of patients who suffer a myocardial infarction.
Secondary	Target Vessel Related MI	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical: The number of patients who suffer a MI that is related to the target vessel of the procedure.
Secondary	Ischemia Driven TLR	30 days, 6 months, and 1, 2, 3, 4 and 5 years	Clinical:

1 to 10 of 17Source ClinicalTrials.gov

See all 17 registered outcomes

Outcomes17

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Target Lesion Failure (TLF)	12 months	percentage of TLF	NUMBER
SECONDARY	Device Success	Determined at time of baseline procedure
SECONDARY	TLF	30 days, 6 months, and 1, 2, 3, 4 and 5 years
SECONDARY	Major Adverse Cardiac Events	30 days, 6 months, and 1, 2, 3, 4 and 5 years
SECONDARY	Target Vessel Failure	30 days, 6 months, and 1, 2, 3, 4 and 5 years
SECONDARY	All Cause Mortality	30 days, 6 months, and 1, 2, 3, 4 and 5 years
SECONDARY	Cardiac Death	30 days, 6 months, and 1, 2, 3, 4 and 5 years
SECONDARY	Myocardial Infarction	30 days, 6 months, and 1, 2, 3, 4 and 5 years
SECONDARY	Target Vessel Related MI	30 days, 6 months, and 1, 2, 3, 4 and 5 years
SECONDARY	Ischemia Driven TLR	30 days, 6 months, and 1, 2, 3, 4 and 5 years

1 to 10 of 17Source ClinicalTrials.gov

See all 17 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Target Lesion Failure (TLF)	BioNIR		5.4	95% Confidence Interval 4.0 to 7.1	percentage of TLF
Target Lesion Failure (TLF)	Resolute		5.4	95% Confidence Interval 4.0 to 7.0	percentage of TLF

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BioNIR	958
Overall Study	STARTED	Resolute	961
Overall Study	COMPLETED	BioNIR	884
Overall Study	COMPLETED	Resolute	878
Overall Study	NOT COMPLETED	BioNIR	74
Overall Study	NOT COMPLETED	Resolute	83

Source ClinicalTrials.gov

Adverse events84

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	BioNIR	5	945
other	Blood and lymphatic system disorders	Blood and lymphatic system disorders	Resolute	1	954
other	Cardiac Disorders	Cardiac disorders	BioNIR	159	945
other	Cardiac Disorders	Cardiac disorders	Resolute	124	954
other	ear and labyrinth disorders	Ear and labyrinth disorders	BioNIR	1	945
other	ear and labyrinth disorders	Ear and labyrinth disorders	Resolute	3	954
other	Eye disorders	Eye disorders	BioNIR	1	945
other	Eye disorders	Eye disorders	Resolute	0	954
other	Gastrointestinal disorders	Gastrointestinal disorders	BioNIR	26	945
other	Gastrointestinal disorders	Gastrointestinal disorders	Resolute	22	954

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BioNIR	5	958
Total, all-cause mortality	Resolute	2	961
Total, other adverse events	BioNIR	370	945
Total, other adverse events	Resolute	364	954
Total, serious adverse events	BioNIR	247	945
Total, serious adverse events	Resolute	242	954

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28794001	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
BioNIR vs Resolute: deaths from any cause	Trial comparisons
BioNIR vs Resolute: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01995487

GET https://conductscience.org/api/trials/v1/NCT01995487/events?page=2

API reference For AI assistants