Clinical Trial: Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: BioNIR Ridaforolimus Eluting Coronary Stent System (BioNIR) In Coronary Stenosis Trial

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.

Detailed Summary:

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. Sponsor: Medinol Ltd.

    Current Primary Outcome: 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

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


    Original Secondary Outcome: Same as current

    Information By: Medinol Ltd.

    Dates:
    Date Received: November 12, 2013
    Date Started: January 2014
    Date Completion:
    Last Updated: May 1, 2016
    Last Verified: May 2016