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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Outcome measures

    The main outcomes focused on procedural success, clinical success and safety outcomes. The measures used are detailed in the following paragraphs.

    Procedural and clinical success

    Procedural success rate

    Defined as completing the procedure with full expansion of the balloon or stent with residual stenosis of less than 30%, or both, and TIMI III flow without any serious angiographic complications.

    Clinical success rate

    Defined as the ability of IVL to achieve a residual stenosis of less than 50% after stent implantation and freedom from MACE.

    Safety measures

    Major adverse cardiovascular events (MACE)

    Defined as the composite of death, MI, and target-vessel revascularisation occurring within a specified follow-up period (for example, in-hospital, 30-days).