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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Medinol Ltd.
Sponsor:
Information provided by (Responsible Party):
Medinol Ltd.
ClinicalTrials.gov Identifier:
NCT01995487
First received: November 12, 2013
Last updated: August 17, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Clinical:

  • Ischemia driven TVR [ Time Frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
    Clinical:

  • Stent Thrombosis [ Time Frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years ] [ Designated as safety issue: Yes ]
    Clinical: ARC definite and probable

  • Angiographic Sub-Study: In-stent and in-segment late loss [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    Secondary Endpoint for angiographic in-stent and in-segment late loss

  • IVUS Sub-Study: In-stent percent neointimal hyperplasia [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    IVUS: In-stent percent neointimal hyperplasia

  • IVUS Sub-Study: Stent mal-apposition [ Time Frame: 13 months ] [ Designated as safety issue: No ]
    IVUS Sub-Study: Stent mal-apposition

  • Lesion Success [ Time Frame: Determined at time of baseline procedure ] [ Designated as safety issue: No ]
    Measures whether the lesion was successfully treated.

  • Procedure Success [ Time Frame: Determined at time of baseline procedure ] [ Designated as safety issue: No ]
    Acute clinical endpoint: The success of the procedure as determined at time of baseline procedure


Estimated Enrollment: 1906
Study Start Date: January 2014
Estimated Primary Completion Date: April 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • 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 and comply with follow-up visits and testing schedule
  • Target lesion(s) must be located in native coronary artery or bypass graft conduit with visually estimated diameter of ≥2.5mm to ≤4.25mm.
  • Complex lesions allowed, including calcified, presence of thrombus, CTO, bifurcation (except as noted in exclusion criteria #30), ostial RCA, tortuous, bare metal stent restenotic, protected left main, and saphenous vein graft
  • Overlapping stents allowed

Exclusion Criteria:

  • STEMI within 24 hours of init. time of presentation to the first treating hospital, or in whom enzyme levels (either CK-MB or Troponin) have not peaked PCI within the 24 hours preceding baseline procedure
  • Non-target lesion PCI in target vessel within 12 months of baseline procedure
  • History of stent thrombosis
  • Cardiogenic shock (defined as persistent hypotension [systolic blood pressure <90mm/Hg for MT 30 minutes] 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 is indicated for chronic oral anticoagulant treatment)
  • Calculated creatinine clearance <30 mL/min using 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 or active bleeding from any site
  • Bleeding from any site within prior 8 weeks requiring active medical or surgical attention
  • If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
  • History of bleeding diathesis or coagulopathy or 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, whether BioNIR or Resolute
  • Known allergy to protocol-required concomitant medications such as aspirin, or DAPT (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
  • Any co-morbid condition that may cause non-compliance with protocol (e.g. dementia, substance abuse) or reduced life expectancy to <24 months (e.g. cancer, severe heart failure, severe lung disease)
  • Patient is participating/plans to participate in another investigational drug/device clinical trial that has not reached its primary endpoint
  • Pregnant or breastfeeding women (women of child-bearing potential must have a negative pregnancy test within 1 week 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 an organ transplant/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 a 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 ClinicalTrials.gov identifier: NCT01995487

Locations
Israel
Hadassah Hebrew University Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Haim Danenberg, MD    +972 2 6776564/3    danen@hadassah.org.il   
Sponsors and Collaborators
Medinol Ltd.
  More Information

No publications provided

Responsible Party: Medinol Ltd.
ClinicalTrials.gov Identifier: NCT01995487     History of Changes
Other Study ID Numbers: BioNIR-001
Study First Received: November 12, 2013
Last Updated: August 17, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Israel: Ministry of Health
Belgium: Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Spain: Comité Ético de Investigación Clínica
Netherlands: Independent Ethics Committee
Poland: Ministry of Health

Keywords provided by Medinol Ltd.:
more comers
DES
BioNIR
ACS
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

ClinicalTrials.gov processed this record on September 11, 2014