Methods
angioplasty
This randomized clinical trial was conducted in 18 well-experienced tertiary endovascular intervention centers in South Korea to compare the efficacy of SENS implantation to balloon angioplasty alone for BTK lesions following successful balloon angioplasty (SENS-BTK trial). The study was conducted in accordance with the ethical guidelines of the 2004 Declaration of Helsinki. Institutional Review Board (IRB) of a Korea University Guro Hospital (KUGH) approved all of the consenting procedures. All patients or their legal guardians were given a thorough written and verbal explanation of the study procedure before obtaining written consent for the participation in this study. The authors of this manuscript have certified that the information contained herein is true and correct as reflected in the records of the IRB (#KUGH MD120008). Angiographic images and data management were analyzed by the Cardiovascular Intervention Research Institution, a core laboratory independent of the sponsor (Abbott Vascular, Redwood City, Santa Clara, California, USA).