NCT01995500

Brief Summary

The NIREUS study aims to demonstrate angiographic non-inferiority for the BioNIR Ridaforolimus Eluting Coronary Stent System (hereafter referred to as BioNIR) in comparison to the Resolute zotarolimus-eluting stent (hereafter referred to as Resolute). The trial hypothesis is that the BioNIR is non-inferior to the Resolute for the primary endpoint of angiographic in-stent late loss at 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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 14, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

March 19, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2015

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2020

Completed
Last Updated

February 21, 2021

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

November 14, 2013

Last Update Submit

February 18, 2021

Conditions

Coronary Artery Stenosis

Keywords

CADPCIACSnon ACSBioNIRDES

Outcome Measures

Primary Outcomes (1)

  • In-stent late loss

    In-stent late loss as measured by the angiographic core laboratory

    6 months

Secondary Outcomes (14)

  • In-segment late loss

    6 months

  • Follow-up percent diameter stenosis

    6 months

  • Binary restenosis

    6 months

  • Length and patterns of angiographic restenosis

    6 months

  • Device, Lesion, and Procedure Success

    Determined at time of baseline procedure

  • +9 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 Coronary Stent System consists of four subsystems: * Endeavor Resolute Stent - a premounted cobalt alloy based stent * Delivery system - Rapid Exchange (RX) Coronary System * Polymer system * Zotarolimus - drug The Resolute has a nominal drug dose of 1.6 µg 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:

  • Age ≥ 18 years
  • Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
  • Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows:
  • a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: \<50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.

You may not qualify if:

  • ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.
  • d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated.
  • Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
  • Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel
  • Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to \<100%.
  • Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent).
  • TIMI flow 2 or 3
  • If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria.
  • Planned procedures after the baseline procedure in either the target or non-target vessels.
  • STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked.
  • PCI within the 24 hours preceding the baseline procedure and randomization.
  • Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.
  • History of stent thrombosis.
  • Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
  • Known LVEF \<30%.
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Hebrew University Medical Center

Jerusalem, 91129, Israel

Location

Related Publications (1)

  • Paradies V, Ben-Yehuda O, Jonas M, Banai S, Iniguez A, Perlman GY, Kandzari DE, Stone GW, Smits PC. A prospective randomised trial comparing the novel ridaforolimus-eluting BioNIR stent to the zotarolimus-eluting Resolute stent: six-month angiographic and one-year clinical results of the NIREUS trial. EuroIntervention. 2018 May 20;14(1):86-93. doi: 10.4244/EIJ-D-17-00890.

    PMID: 29537374DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
phase 2
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 14, 2013

First Posted

November 26, 2013

Study Start

March 19, 2014

Primary Completion

March 19, 2015

Study Completion

June 17, 2020

Last Updated

February 21, 2021

Record last verified: 2020-05

Locations

IL(1)