Status:
RECRUITING
Drug-Coated Balloon in Patients With High Bleeding Risk
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Seoul St. Mary's Hospital
Seoul National University Bundang Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief 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-elutin...
Detailed Description
Second-generation DES is the standard of care for patients with coronary artery disease who are deemed eligible for percutaneous coronary intervention (PCI). Despite many advantages, DES inevitably ac...
Eligibility Criteria
Inclusion
- Subject must be at least 19 years of age
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- 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
- 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
- Patients unable to provide consent
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- 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
- Patients who have non-cardiac co-morbid conditions with life expectancy \<2 year
- Patients who may result in protocol non-compliance (site investigator's medical judgment)
- Patients with cardiogenic shock or cardiac arrest
- Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
- Patients with severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
1350 Patients enrolled
Trial Details
Trial ID
NCT05221931
Start Date
July 29 2022
End Date
December 1 2028
Last Update
December 19 2025
Active Locations (17)
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1
Korea University Ansan Hospital
Ansan, South Korea
2
Chungbuk National University
Cheongju-si, South Korea
3
Keimyung University Dongsan Hospital
Daegu, South Korea
4
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung, South Korea