Drug-Coated Balloon in Patients With High Bleeding Risk
Condition(s) studied
Investigational drug(s) / intervention(s)
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 \[B-Braun, Germany\])
Study 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).
Eligibility
Primary outcome measure(s)
- Target vessel failure (TVF) — 2 years from last patient enrollment
a composite of cardiovascular death, target-vessel myocardial infarction (MI), and clinically indicated target-vessel revascularization (TVR)
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Samsung Medical Center trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05221931 on ClinicalTrials.gov ↗ ← All trials in South Korea