Drug-Coated Balloon in Patients With High Bleeding Risk
NCT05221931 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1359
Last updated 2026-02-12
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).
Conditions
Interventions
- PROCEDURE
-
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 \[B-Braun, Germany\])
Sponsors & Collaborators
-
Seoul St. Mary's Hospital
collaborator OTHER -
Seoul National University Bundang Hospital
collaborator OTHER -
Korea University Ansan Hospital
collaborator OTHER -
Chonnam National University Hospital
collaborator OTHER -
Chung-Ang University Gwangmyeong Hospital
collaborator OTHER -
Gangneung Asan Hospital, University of Ulsan College of Medicine
collaborator UNKNOWN -
Gyeongsang National University Hospital
collaborator OTHER -
Uijeongbu St. Mary Hospital
collaborator OTHER -
Keimyung University Dongsan Medical Center
collaborator OTHER -
Inha University Hospital
collaborator OTHER -
Chungbuk National University
collaborator OTHER -
Wonju Severance Christian Hospital
collaborator OTHER -
SMG-SNU Boramae Medical Center
collaborator OTHER -
Kangbuk Samsung Hospital, Sungkyunkwan University
collaborator OTHER -
Ewha Womans University
collaborator OTHER -
Korea University Guro Hospital
collaborator OTHER -
Samsung Medical Center
lead OTHER
Principal Investigators
-
Joo Myung Lee, MD, PhD · Samsung Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-29
- Primary Completion
- 2027-11-30
- Completion
- 2028-12-31
Countries
- South Korea
Study Locations
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