Coronary Artery StenosisBIONICSNCT01995487
Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
A study testing BioNIR and Resolute in people with Coronary Artery Stenosis, run by Medinol Ltd. at 8 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- BioNIR and Resolute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,919 participants
- Where
- 8 sitesin 8 countries
- Study dates
- Jan 2014to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with indication for PCI including angina/silent ischemia/NSTEMI/recent STEMI
- Non-target vessel PCI allowed prior to randomization depending on time interval and certain conditions
- Patient/legal guardian willing \& able to provide informed written consent \& comply with follow-up visits \& testing schedule
- Target lesion(s) must be located in native coronary artery/bypass graft conduit w/visually estimated diameter ≥2.5mm to ≤4.25mm.
- Complex lesions allowed, including calcified, presence of thrombus, CTO, bifurcation (except as per exclusion criteria #30), ostial RCA, tortuous, bare metal stent restenotic, protected left main, and saphenous vein graft
Who cannot join
- STEMI within 24 hours of init. time of presentation to first treating hospital, or in whom enzyme levels (either CK-MB or Troponin) have not peaked
- PCI within 24 hours preceding baseline procedure
- Non-target lesion PCI in target vessel within 12 months of baseline procedure
- History of stent thrombosis
- Cardiogenic shock (persistent hypotension [systolic blood pressure <90mm/Hg for MT 30 min] or requiring pressors/hemodynamic support, including IABP)
- Subject is intubated
Show all 33Show fewer
- Known LVEF <30%
- Relative/absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject indicated for chronic oral anticoagulant treatment)
- Calculated creatinine clearance <30 mL/min per Cockcroft-Gault equation (<40mL/min for subjects participating in angiographic follow-up sub-study)
- Hemoglobin <10g/dL
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3
- White blood cell (WBC) count <3,000 cells/mm3
- Clinically significant liver disease
- Active peptic ulcer/active bleeding from any site
- Bleeding from any site within prior 8 wks requiring active medical/surgical attention
- If femoral access is planned, significant peripheral arterial disease that precludes safe insertion of 6F sheath
- History of bleeding diathesis/coagulopathy/will refuse blood transfusions
- Cerebrovascular accident/transient ischemic attack within past 6 months, or any permanent neurologic defect attributed to CVA
- Known allergy to study stent components, BioNIR or Resolute
- Known allergy to protocol-required concomitant medications: aspirin/DAPT (clopidogrel, prasugrel, ticagrelor)/heparin and bivalirudin/iodinated contrast that cannot be adequately pre-medicated
- Any co-morbid condition that may cause non-compliance with protocol (e.g. dementia, substance abuse) /reduced life expectancy to <24 months (e.g. cancer, severe heart failure, severe lung disease)
- Patient participating/plans to participate in another investigational drug/device clinical trial that has not reached its primary endpoint
- Pregnant/breastfeeding women (women of child-bearing potential must have a negative pregnancy test within 1 wk before treatment)
- Women who intend to become pregnant within 12 months after baseline procedure (sexually active women of child-bearing potential must agree to use a reliable method of contraception from time of screening through 12 months post baseline procedure)
- Patient has received/is on a waiting list for an organ transplant
- Patient receiving/scheduled to receive chemotherapy within 30 days before/any time after the baseline procedure
- Patient receiving oral/intravenous immunosuppressive therapy or has known life-limiting immunosuppressive/autoimmune disease (e.g. HIV); corticosteroids are allowed
- More than 100mm length of planned stenting in the entire coronary tree
- Unprotected left main lesions ≥30%, or planned left main intervention
- Ostial LAD/LCX lesions (stenting of any diseased segment within 5mm of the unprotected left main coronary artery)
- Bifurcation lesions with planned dual stent implantation
- Stenting of lesions due to DES restenosis
- Another lesion in a target/non-target vessel (including all side branches) is present that requires/has high probability of requiring PCI within 12 months after baseline procedure
Trial locations and contacts
8 sites in 8 countries.
8 sites in 8 countries
Canada1 site
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial
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.
Read the detailed description
The BioNIR is a prospective, multi-center, single-blind, two-arm, randomized clinical trial. The population will consist of subjects undergoing PCI for angina (stable or unstable), silent ischemia, NSTEMI, and recent STEMI. Complex lesions are allowed. There is no limit to the number of lesions per vessel or individual lesion length; however, the total planned stenting in the coronary tree cannot exceed 100mm.
Randomization will be stratified by the presence of medically treated diabetes vs. no medically treated diabetes, acute coronary syndrome (ACS) vs. non-ACS, and by site. Lesions planned to be treated must be declared and recorded at time of randomization. Planned staged procedures, if necessary, must be declared immediately post procedure.
Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization. 200 patients at participating North American sites will be consented for planned angiographic follow-up at 13 months after enrollment, with 100 of these patients consented to undergo planned IVUS at baseline and at 13 months following randomization.
The primary endpoint is Target Lesion Failure (TLF) at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5, except as noted:
- Device, Lesion, and Procedure Success at time of baseline procedure
- TLF 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.
- Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR)
- Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
- All-cause mortality
- Cardiac death
- Myocardial Infarction
- Target Vessel Related MI
- Ischemia-driven TLR
- Ischemia-driven TVR
- Stent Thrombosis (ARC definite and probable)
Angiographic Sub-Study Secondary Endpoint to be evaluated at 13 months:
- Angiographic in-stent and in-segment late loss
IVUS Sub-Study Secondary Endpoint to be evaluated at 13 months:
- In-stent percent neointimal hyperplasia
- Stent mal-apposition
A key component of this trial will be a prospective assessment of health care resource utilization, costs and cost effectiveness. A separate cost effectiveness assessment plan describes the data collection and analysis.
Sample Size Consideration: From recent US trials of best in class DES (Xience V, Promus Element and Resolute), the 1-year TLF rate in patients with non-complex lesions not undergoing routine angiographic follow-up is approximately 3.8%. Using the assumption of the more-comers' design, the 1-year event rate will be conservatively increased by 50% (assuming enrollment rate for complex patients/lesions is 50% with double the standard event rate) - thus 5.8%. Therefore, with a one-sided 95% upper bound of the confidence interval of 3.3% (a relative 57% margin) and 1:1 randomization, enrolling 1810 patients (905 per group) provides 90% power to demonstrate non-inferiority. Assuming 95% follow-up rate at 1 year, approximately 1906 patients will be enrolled (953 in each group).
- Conditions
- Coronary Artery Stenosis
- Being tested
- BioNIR, Resolute
- Keywords
- more comers, DES, BioNIR, ACS, non ACS, complex lesions
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioNIRDevice
drug-eluting stent
ResoluteDevice
drug-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| BioNIR | Experimental | 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). Receives: Device: BioNIR |
| Resolute | Active comparator | 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. Receives: Device: Resolute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
The primary endpoint of TLF at 12 months was defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
Measured: 12 months
Secondary outcomes (16)
Device Success
Clinical: Acute secondary endpoint determined at time of baseline procedure
Measured: Determined at time of baseline procedure
TLF
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
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Major Adverse Cardiac Events
Clinical: MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Failure
Clinical: TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
All Cause Mortality
Clinical: The number of patients who die from all causes
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Cardiac Death
Clinical: The number of patients who die of cardiac-related causes
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Myocardial Infarction
Clinical: The number of patients who suffer a myocardial infarction.
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Related MI
Clinical: The number of patients who suffer a MI that is related to the target vessel of the procedure.
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia Driven TLR
Clinical:
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia Driven TVR
Clinical:
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Stent Thrombosis
Clinical: ARC definite and probable
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Angiographic Sub-Study: In-stent and In-segment Late Loss
Secondary Endpoint for angiographic in-stent and in-segment late loss
Measured: 13 months
IVUS Sub-Study: In-stent Percent Neointimal Hyperplasia
IVUS: In-stent percent neointimal hyperplasia
Measured: 13 months
IVUS Sub-Study: Stent Mal-apposition
IVUS Sub-Study: Stent mal-apposition
Measured: 13 months
Lesion Success
Measures whether the lesion was successfully treated.
Measured: Determined at time of baseline procedure
Procedure Success
Acute clinical endpoint: The success of the procedure as determined at time of baseline procedure
Measured: Determined at time of baseline procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion28 Aug 2016
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Drug-Device combination Product.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,919 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinol Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995487
- Sponsor's protocol ID
- BioNIR-001
- Acronym
- BIONICS
- Status last verified
- Oct 2023
- First submitted
- 12 Nov 2013
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kandzari DE, Smits PC, Love MP, Ben-Yehuda O, Banai S, Robinson SD, Jonas M, Kornowski R, Bagur R, Iniguez A, Danenberg H, Feldman R, Jauhar R, Chandna H, Parikh M, Perlman GY, Balcells M, Markham P, Ozan MO, Genereux P, Edelman ER, Leon MB, Stone GW. Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis). Circulation. 2017 Oct 3;136(14):1304-1314. doi: 10.1161/CIRCULATIONAHA.117.028885. Epub 2017 Aug 9.
PubMed 28794001
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial
- ClinicalTrials.gov ID
- NCT01995487
- Acronym / sponsor ID
- BIONICS / BioNIR-001
- Conditions
- Coronary Artery Stenosis
- Keywords
- more comers, DES, BioNIR, ACS, non ACS, complex lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,919 participants (actual)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- 28 Aug 2016 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 25 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The BioNIR is a prospective, multi-center, single-blind, two-arm, randomized clinical trial. The population will consist of subjects undergoing PCI for angina (stable or unstable), silent ischemia, NSTEMI, and recent STEMI. Complex lesions are allowed. There is no limit to the number of lesions per vessel or individual lesion length; however, the total planned stenting in the coronary tree cannot exceed 100mm.
Randomization will be stratified by the presence of medically treated diabetes vs. no medically treated diabetes, acute coronary syndrome (ACS) vs. non-ACS, and by site. Lesions planned to be treated must be declared and recorded at time of randomization. Planned staged procedures, if necessary, must be declared immediately post procedure.
Clinical follow-up will be performed at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post randomization. 200 patients at participating North American sites will be consented for planned angiographic follow-up at 13 months after enrollment, with 100 of these patients consented to undergo planned IVUS at baseline and at 13 months following randomization.
The primary endpoint is Target Lesion Failure (TLF) at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
Clinical Secondary Endpoints to be evaluated at 30 days, 6 months, and 1, 2, 3, 4 and 5, except as noted:
- Device, Lesion, and Procedure Success at time of baseline procedure
- TLF 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.
- Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR)
- Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
- All-cause mortality
- Cardiac death
- Myocardial Infarction
- Target Vessel Related MI
- Ischemia-driven TLR
- Ischemia-driven TVR
- Stent Thrombosis (ARC definite and probable)
Angiographic Sub-Study Secondary Endpoint to be evaluated at 13 months:
- Angiographic in-stent and in-segment late loss
IVUS Sub-Study Secondary Endpoint to be evaluated at 13 months:
- In-stent percent neointimal hyperplasia
- Stent mal-apposition
A key component of this trial will be a prospective assessment of health care resource utilization, costs and cost effectiveness. A separate cost effectiveness assessment plan describes the data collection and analysis.
Sample Size Consideration: From recent US trials of best in class DES (Xience V, Promus Element and Resolute), the 1-year TLF rate in patients with non-complex lesions not undergoing routine angiographic follow-up is approximately 3.8%. Using the assumption of the more-comers' design, the 1-year event rate will be conservatively increased by 50% (assuming enrollment rate for complex patients/lesions is 50% with double the standard event rate) - thus 5.8%. Therefore, with a one-sided 95% upper bound of the confidence interval of 3.3% (a relative 57% margin) and 1:1 randomization, enrolling 1810 patients (905 per group) provides 90% power to demonstrate non-inferiority. Assuming 95% follow-up rate at 1 year, approximately 1906 patients will be enrolled (953 in each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a Drug-Device combination Product.
| Arm | Type | Receives |
|---|---|---|
| BioNIR | Experimental | Device: BioNIRThe 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). |
| Resolute | Active comparator | Device: ResoluteThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with indication for PCI including angina/silent ischemia/NSTEMI/recent STEMI
- Non-target vessel PCI allowed prior to randomization depending on time interval and certain conditions
- Patient/legal guardian willing \& able to provide informed written consent \& comply with follow-up visits \& testing schedule
- Target lesion(s) must be located in native coronary artery/bypass graft conduit w/visually estimated diameter ≥2.5mm to ≤4.25mm.
- Complex lesions allowed, including calcified, presence of thrombus, CTO, bifurcation (except as per exclusion criteria #30), ostial RCA, tortuous, bare metal stent restenotic, protected left main, and saphenous vein graft
Key exclusion criteria (33 listed)
- STEMI within 24 hours of init. time of presentation to first treating hospital, or in whom enzyme levels (either CK-MB or Troponin) have not peaked
- PCI within 24 hours preceding baseline procedure
- Non-target lesion PCI in target vessel within 12 months of baseline procedure
- History of stent thrombosis
- Cardiogenic shock (persistent hypotension [systolic blood pressure <90mm/Hg for MT 30 min] or requiring pressors/hemodynamic support, including IABP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioNIRdrug-eluting stent | Device | BioNIR |
| Resolutedrug-eluting stent | Device | Resolute |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 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.
16 secondary outcomes
Device Success
Time frame: Determined at time of baseline procedure
TLF
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Major Adverse Cardiac Events
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Failure
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
All Cause Mortality
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Cardiac Death
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Myocardial Infarction
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Related MI
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia Driven TLR
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia Driven TVR
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Stent Thrombosis
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Angiographic Sub-Study: In-stent and In-segment Late Loss
Time frame: 13 months
IVUS Sub-Study: In-stent Percent Neointimal Hyperplasia
Time frame: 13 months
IVUS Sub-Study: Stent Mal-apposition
Time frame: 13 months
Lesion Success
Time frame: Determined at time of baseline procedure
Procedure Success
Time frame: Determined at time of baseline procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28794001Kandzari DE, Smits PC, Love MP, Ben-Yehuda O, Banai S, Robinson SD, Jonas M, Kornowski R, Bagur R, Iniguez A, Danenberg H, Feldman R, Jauhar R, Chandna H, Parikh M, Perlman GY, Balcells M, Markham P, Ozan MO, Genereux P, Edelman ER, Leon MB, Stone GW. Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis). Circulation. 2017 Oct 3;136(14):1304-1314. doi: 10.1161/CIRCULATIONAHA.117.028885. Epub 2017 Aug 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioNIR and Resolute in people with Coronary Artery Stenosis, run by Medinol Ltd. at 8 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, Canada, Israel, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.