NCT01995487

Brief 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 months; and that it is more cost-effective.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,919

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
8 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2016

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 25, 2021

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

2.7 years

First QC Date

November 12, 2013

Results QC Date

August 12, 2020

Last Update Submit

October 1, 2023

Conditions

Coronary Artery Stenosis

Keywords

more comersDESBioNIRACSnon ACScomplex lesions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (16)

  • Device Success

    Determined at time of baseline procedure

  • TLF

    30 days, 6 months, and 1, 2, 3, 4 and 5 years

  • Major Adverse Cardiac Events

    30 days, 6 months, and 1, 2, 3, 4 and 5 years

  • Target Vessel Failure

    30 days, 6 months, and 1, 2, 3, 4 and 5 years

  • All Cause Mortality

    30 days, 6 months, and 1, 2, 3, 4 and 5 years

  • +11 more secondary outcomes

Study Arms (2)

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).

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.

Device: Resolute

Interventions

BioNIRDEVICE

drug-eluting stent

BioNIR
ResoluteDEVICE

drug-eluting stent

Resolute

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

ZNA Middelheim

Antwerp, Belgium

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Hadassah Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

San Raffaele Hospital

Milan, 20162, Italy

Location

Maasstad Ziekenhuis

Rotterdam, 3079 DZ, Netherlands

Location

PAKS, II Oddzial Kardiologiczny

Bielsko-Biala, 43-316, Poland

Location

Hospital Meixoeiro

Pontevedra, VIGO, 36200, Spain

Location

Related Publications (1)

  • 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.

    PMID: 28794001DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Results Point of Contact

Title
Dina Kofler, VP Clinical Affairs
Organization
Medinol
dinak@medinol.com
+97237679032

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a Drug-Device combination Product.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 26, 2013

Study Start

January 1, 2014

Primary Completion

August 28, 2016

Study Completion

November 30, 2020

Last Updated

October 16, 2023

Results First Posted

February 25, 2021

Record last verified: 2023-10

Locations

IT(1)ES(1)NL(1)IL(1)PL(1)BE(1)US(1)CA(1)