Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2

NARecruitingINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

April 7, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2031

Conditions
Chronic Coronary Syndrome
Interventions
OTHER

Discontinuation of antiplatelet agent group

In this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization.

OTHER

Continuation of antiplatelet agent group

In this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion.

Trial Locations (17)

Unknown

NOT_YET_RECRUITING

Korea University Ansan Hospital, Ansan

NOT_YET_RECRUITING

Keimyung University Dongsan Medical Center, Daegu

NOT_YET_RECRUITING

Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung

NOT_YET_RECRUITING

Ilsan Paik hospital, Goyang

NOT_YET_RECRUITING

Chonnam National University Hospital, Chonnam National University Medical School, Gwangju

NOT_YET_RECRUITING

Chung-Ang University Gwangmyeong Hospital, Gwangmyeong

NOT_YET_RECRUITING

Catholic Kwandong University International St. Mary's Hospital, Incheon

NOT_YET_RECRUITING

Gachon Cardiovascular Research Institute, Gachon University, Incheon

NOT_YET_RECRUITING

Inha University Hospital, Incheon

NOT_YET_RECRUITING

Chonbuk National University Hospital and Chonbuk National University Medical School, Jeonju

NOT_YET_RECRUITING

Gyeongsang National University Hospital, Jinju

NOT_YET_RECRUITING

Kangbuk Samsung Hospital, Seoul

NOT_YET_RECRUITING

Korea University Guro Hospital, Seoul

RECRUITING

Samsung Medical Center, Seoul

NOT_YET_RECRUITING

SMG-SNU Boramae Medical Center, Seoul

NOT_YET_RECRUITING

Ajou University School of Medicine, Suwon

NOT_YET_RECRUITING

Uijeongbu St. Mary Hospital, Uijeongbu-si

All Listed Sponsors
collaborator

Chonnam National University Hospital

OTHER

lead

Samsung Medical Center

OTHER