256
Participants
Start Date
August 18, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2028
Drug-eluting stent implantation
"IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio \>0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups.~In DES group, latest second-generation DES will be used in accordance with standard practice guideline."
Drug-coated balloon angioplasty
"IVUS (OPTICROSS, Boston Scientific, USA) will be recommended to select proper size of predilatation balloon (semi- or non-compliant balloon), DCB, or DES. Optimal lesion preparation is defined as satisfying all of the followings: 1) a fully inflated balloon of the correct size for the vessel (balloon with vessel ratio \>0.90); 2) ≤35% residual stenosis; 3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3; and 4) the absence of a flow-limiting coronary artery dissection.15 After successful lesion preparation, patients will receive either DCB or DES according to randomly allocated groups.~In DCB group, commercially available DCB (Agent, Boston Scientific, USA) will be used. DCB angioplasty will be recommended as follows to fully optimized procedural results. First, DCB size should be 1:1 ratio with reference vessel size. Second, delivery time of DCB should be within 30 seconds. Third, total inflation time of DCB will be recommended from 30 to 60 seconds."
NOT_YET_RECRUITING
Keimyung University Dongsan Hospital, Daegu
NOT_YET_RECRUITING
Ulsan University Hospital, Ulsan
NOT_YET_RECRUITING
Kosin University Gospel Hospital, Busan
NOT_YET_RECRUITING
Jeonbuk National University Hospital, Jeonju
NOT_YET_RECRUITING
Yeosu Jeil Hospital, Yeosu
RECRUITING
Chonnam National University, Gwangju
NOT_YET_RECRUITING
Samsung Medical Center, Seoul
NOT_YET_RECRUITING
Ewha Womans University Mokdong Hospital, Seoul
NOT_YET_RECRUITING
Korea University Guro Hospital, Seoul
Collaborators (1)
Boston Scientific Corporation
INDUSTRY
Chonnam National University Hospital
OTHER