Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions

NARecruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

August 18, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Coronary Artery Disease
Interventions
PROCEDURE

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."

PROCEDURE

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."

Trial Locations (9)

42601

NOT_YET_RECRUITING

Keimyung University Dongsan Hospital, Daegu

44033

NOT_YET_RECRUITING

Ulsan University Hospital, Ulsan

49269

NOT_YET_RECRUITING

Kosin University Gospel Hospital, Busan

54907

NOT_YET_RECRUITING

Jeonbuk National University Hospital, Jeonju

59677

NOT_YET_RECRUITING

Yeosu Jeil Hospital, Yeosu

61469

RECRUITING

Chonnam National University, Gwangju

06351

NOT_YET_RECRUITING

Samsung Medical Center, Seoul

07985

NOT_YET_RECRUITING

Ewha Womans University Mokdong Hospital, Seoul

08308

NOT_YET_RECRUITING

Korea University Guro Hospital, Seoul

Sponsors
All Listed Sponsors
collaborator

Boston Scientific Corporation

INDUSTRY

lead

Chonnam National University Hospital

OTHER