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Active, not recruiting Not applicable

Drug-Coated Balloon in Patients With High Bleeding Risk

NCT05221931 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2022-07-29
Last updated
2026-02-12

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Percutaneous coronary intervention

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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject must be at least 19 years of age 2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. 3. Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve ≤0.80 requiring revascularization in de-novo coronary artery of reference vessel size ≥2.25 mm 4. Patients with high bleeding risk: one or more of the criteria listed (1) Adjunctive oral anticoagulation treatment planned to continue after PCI (2) Age ≥ 75 years old (3) Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) (4) Any prior intra-cerebral bleeding (5) Stroke at any time or transient ischemic attack in the previous 6 months. (6) Hospital admission for bleeding during the prior 12 months (7) Non skin cancer diagnosed or treated \< 3 years (8) Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI (9) Planned surgery that would require interruption of DAPT (within next 12 months) (10) Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis (11) Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) (12) Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice (13) Expected non-compliance to prolonged DAPT for other medical reasons Exclusion Criteria: 1. Patients unable to provide consent 2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents 3. Patients with angiographic findings of (1) Left main coronary artery disease (2) In-stent restenosis is the cause of target lesion (3) Target lesion in bypass graft (4) True bifurcation lesion that requires upfront 2-stenting 4. Patients who have non-cardiac co-morbid conditions with life expectancy \<2 year 5. Patients who may result in protocol non-compliance (site investigator's medical judgment) 6. Patients with cardiogenic shock or cardiac arrest 7. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 8. Patients with severe valvular heart disease requiring open heart surgery 9. Pregnant or lactating women

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)

FacilityCityRegionStatus
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
Official registry record

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