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ACTIVE NOT RECRUITING
NCT05221931
NA

Drug-Coated Balloon in Patients With High Bleeding Risk

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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

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 \[B-Braun, Germany\])

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