This was a multicenter (two centers in Poland) randomized, controlled study that enrolled patients between 2018 and 2020. Patients were enrolled if an informed consent form was signed and all inclusion criteria and no exclusion criteria were met. The inclusion and exclusion criteria are provided in Table 1 [14 (link)].
Patients were randomized 1:1 to a BiOSS LIM C stent group versus a regular DES (rDES) group. The following rDESs were used: Xience (Abbott Laboratories, Warsaw, Poland), Resolute Onyx (Medtronic Poland, Warsaw, Poland), Orsiro (Biotronik Polska, Poznan, Poland), Synergy (Boston Scientific Polska, Warsaw, Poland), and Promus Elite (Boston Scientific). This study’s protocol was compliant with SPIRIT guidelines [15 (link)]. An independent Ethics Committee approved the study protocol (No. 14/2018) (ClinicalTrials.gov NCT03548272).
Patients were randomized 1:1 to a BiOSS LIM C stent group versus a regular DES (rDES) group. The following rDESs were used: Xience (Abbott Laboratories, Warsaw, Poland), Resolute Onyx (Medtronic Poland, Warsaw, Poland), Orsiro (Biotronik Polska, Poznan, Poland), Synergy (Boston Scientific Polska, Warsaw, Poland), and Promus Elite (Boston Scientific). This study’s protocol was compliant with SPIRIT guidelines [15 (link)]. An independent Ethics Committee approved the study protocol (No. 14/2018) (ClinicalTrials.gov NCT03548272).
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