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Drug-Coated Balloon in Patients With High Bleeding Risk
Sponsor: Samsung Medical Center
Summary
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial. The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of de-novo coronary lesion in patients with high bleeding risk (HBR).
Official title: Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk (DCB-HBR Trial)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1359
Start Date
2022-07-29
Completion Date
2028-12
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Percutaneous coronary intervention
1:1 randomization to DES (Ultimaster Tansei) or DCB (Agent \[Boston Scientific, USA\], Prevail \[Medtronic, USA\], or SeQuent Please, SeQuent Please NEO \[B-Braun, Germany\])
Locations (17)
Korea University Ansan Hospital
Ansan, South Korea
Chungbuk National University
Cheongju-si, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Inha University Hospital
Incheon, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Ewha Womans University College of Medicine
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Kuro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, South Korea
The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea