Actively Recruiting
Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
Led by Samsung Medical Center · Updated on 2025-11-28
1200
Participants Needed
18
Research Sites
351 weeks
Total Duration
On this page
Sponsors
S
Samsung Medical Center
Lead Sponsor
C
Chonnam National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.
CONDITIONS
Official Title
Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 19 years of age
- Able to understand risks, benefits, and treatment alternatives and provide voluntary consent
- Diagnosed with chronic coronary syndrome and have at least one new lesion with vessel size 2.25 mm or larger treated with DCB angioplasty
- High bleeding risk defined by one or more of the following: age 75 or older; hemoglobin below 11 g/dl or recent anemia treatment; prior brain bleeding; hospital admission for bleeding in the past year; recent non-skin cancer diagnosis or treatment; planned daily NSAID or steroid use longer than 30 days after PCI; planned surgery requiring DAPT interruption within 12 months; kidney failure with creatinine clearance below 40 ml/min or on dialysis; blood disorders including low platelet count or coagulation issues; severe chronic liver disease with complications; expected non-compliance with secondary prevention medications
- Completed standard dual antiplatelet therapy (1 to 3 months) and maintained single antiplatelet therapy (aspirin or P2Y12 inhibitor) for at least 1 year
- No bleeding classified as BARC 2, 3, or 5 or ischemic events (cardiovascular death, non-fatal myocardial infarction, or repeat revascularization) for at least 1 year from initial procedure
You will not qualify if you...
- Unable to provide informed consent
- Having acute myocardial infarction or unstable angina
- Known intolerance to aspirin, P2Y12 inhibitors, or components of the drug-coated balloon
- Indication for oral anticoagulant use
- Received drug-eluting stent implantation during the initial PCI
- History of ischemic stroke or previous myocardial infarction
- Peripheral arterial occlusive disease
- Specific angiographic findings: left main coronary artery disease, in-stent restenosis causing target lesion, target lesion in bypass graft, complex bifurcation lesion needing two stents, or significant residual stenosis on non-target vessels
- Non-cardiac conditions with life expectancy less than 1 year
- Conditions leading to expected protocol non-compliance
- Cardiogenic shock or cardiac arrest
- Severe left ventricular systolic dysfunction with ejection fraction below 30%
- Severe valvular heart disease requiring open heart surgery
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Korea University Ansan Hospital
Ansan, South Korea
Actively Recruiting
2
Keimyung University Dongsan Medical Center
Daegu, South Korea
Actively Recruiting
3
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung, South Korea
Actively Recruiting
4
Ilsan Paik hospital
Goyang, South Korea
Actively Recruiting
5
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, South Korea
Actively Recruiting
6
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Actively Recruiting
7
Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea
Actively Recruiting
8
Gachon Cardiovascular Research Institute, Gachon University
Incheon, South Korea
Actively Recruiting
9
Inha University Hospital
Incheon, South Korea
Actively Recruiting
10
Chonbuk National University Hospital and Chonbuk National University Medical School
Jeonju, South Korea
Actively Recruiting
11
Gyeongsang National University Hospital
Jinju, South Korea
Actively Recruiting
12
Chung-Ang University Hospital
Seoul, South Korea
Actively Recruiting
13
Kangbuk Samsung Hospital
Seoul, South Korea
Actively Recruiting
14
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
15
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
16
SMG-SNU Boramae Medical Center
Seoul, South Korea
Actively Recruiting
17
Ajou University School of Medicine
Suwon, South Korea
Actively Recruiting
18
Uijeongbu St. Mary Hospital
Uijeongbu-si, South Korea
Actively Recruiting
Research Team
J
Joo Myung Lee, MD, MPH, PhD
CONTACT
S
Seung Hun Lee, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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