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Protocol
Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial
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  • Published on:
    Protocol extension
    • Tommaso Gori, Principal Investigator of the study. University Medical Center Mainz

    Dear Editors,
    We would like to inform you and the readers of BMJ open that we plan to slightly enlarge the enrollment of our trial "Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial", which was published in BMJ Open. 2020; 10(6): e034264. Our original intention was to recruit 50 patients. Unfortunately, the OCT data pertaining the primary endpoint of the study could not be assessed in two of the patients. We therefore plan to recruit 2 additional patients following the same procedures. The analysis population of the study will therefore maintain its previously planned size of 50, the safety and IIT populations will however include all 52 patients.

    Safety outcomes have been and will be regularly reviewed by three cardiologists who are not involved in any procedure of the study.

    Sincerely,
    Tommaso Gori

    Conflict of Interest:
    None declared.