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Study of BioNIR Drug Eluting Stent System in Coronary Stenosis (BIONICS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medinol Ltd. Identifier:
First received: November 12, 2013
Last updated: May 28, 2017
Last verified: May 2017
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.

Condition Intervention Phase
Coronary Artery Stenosis Device: BioNIR Device: Resolute Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial

Further study details as provided by Medinol Ltd.:

Primary Outcome Measures:
  • Target Lesion Failure (TLF) [ Time Frame: 12 months ]
    TLF is defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.

Secondary Outcome Measures:
  • Device Success [ Time Frame: Determined at time of baseline procedure ]
    Clinical: Acute secondary endpoint determined at time of baseline procedure

  • TLF [ Time Frame: 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

  • Major adverse cardiac events [ Time Frame: 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

  • Target vessel failure [ Time Frame: 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

  • All cause mortality [ Time Frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years ]
    Clinical: The number of patients who die from all causes

  • Cardiac death [ Time Frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years ]
    Clinical: The number of patients who die of cardiac-related causes

  • Myocardial infarction [ Time Frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years ]
    Clinical: The number of patients who suffer a myocardial infarction.

  • Target vessel related MI [ Time Frame: 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.

  • 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 ]
    Clinical: ARC definite and probable

  • Angiographic Sub-Study: In-stent and in-segment late loss [ Time Frame: 13 months ]
    Secondary Endpoint for angiographic in-stent and in-segment late loss

  • IVUS Sub-Study: In-stent percent neointimal hyperplasia [ Time Frame: 13 months ]
    IVUS: In-stent percent neointimal hyperplasia

  • IVUS Sub-Study: Stent mal-apposition [ Time Frame: 13 months ]
    IVUS Sub-Study: Stent mal-apposition

  • Lesion Success [ Time Frame: Determined at time of baseline procedure ]
    Measures whether the lesion was successfully treated.

  • Procedure Success [ Time Frame: Determined at time of baseline procedure ]
    Acute clinical endpoint: The success of the procedure as determined at time of baseline procedure

Estimated Enrollment: 1906
Study Start Date: January 2014
Estimated Study Completion Date: August 2020
Primary Completion Date: August 28, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BioNIR

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).

Device: BioNIR
drug-eluting stent
Active Comparator: Resolute

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.
Device: Resolute
drug-eluting stent

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01995487

United States, Georgia
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
ZNA Middelheim
Antwerp, Belgium
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 91120
San Raffaele Hospital
Milan, Italy, 20162
Maasstad Ziekenhuis
Rotterdam, Netherlands, 3079 DZ
PAKS, II Oddzial Kardiologiczny
Bielsko-biala, Poland, 43-316
Hospital Meixoeiro
Pontevedra, Vigo, Spain, 36200
Sponsors and Collaborators
Medinol Ltd.
  More Information

Responsible Party: Medinol Ltd. Identifier: NCT01995487     History of Changes
Other Study ID Numbers: BioNIR-001
Study First Received: November 12, 2013
Last Updated: May 28, 2017

Keywords provided by Medinol Ltd.:
more comers
non ACS
complex lesions

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on August 18, 2017