Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2

Recruiting now · Not applicable

Conditions studied: Chronic Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT06742931

Run by

Samsung Medical Center

People needed

1200

Starts

2025-04-07

Expected to finish

2031-12-31

Last updated by the study team

2025-11-28

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
• Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated < 3 years F. Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis I. Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons
• Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.
• No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure.

You may not qualify if…

• Patients unable to provide consent
• Patients with acute myocardial infarction or unstable angina
• Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
• Patients with indication of oral anticoagulant
• Patients with concomitant drug-eluting stent implantation during index PCI
• Patients with history of ischemic stroke or previous myocardial infarction
• Patients with peripheral arterial occlusive disease
• Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront 2-stenting E. Patients with residual stenosis on non-target vessels after PCI (>70% diameter stenosis or FFR≤0.80)
• Patients who have non-cardiac co-morbid conditions with life expectancy <1 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

Where it is running

• Korea University Ansan Hospital — Ansan, South Korea (enrolling)
• Keimyung University Dongsan Medical Center — Daegu, South Korea (enrolling)
• Gangneung Asan Hospital, University of Ulsan College of Medicine — Gangneung, South Korea (enrolling)
• Ilsan Paik hospital — Goyang, South Korea (enrolling)
• Chonnam National University Hospital, Chonnam National University Medical School — Gwangju, South Korea (enrolling)
• Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, South Korea (enrolling)
• Catholic Kwandong University International St. Mary's Hospital — Incheon, South Korea (enrolling)
• Gachon Cardiovascular Research Institute, Gachon University — Incheon, South Korea (enrolling)
• Inha University Hospital — Incheon, South Korea (enrolling)
• Chonbuk National University Hospital and Chonbuk National University Medical School — Jeonju, South Korea (enrolling)
• Gyeongsang National University Hospital — Jinju, South Korea (enrolling)
• Chung-Ang University Hospital — Seoul, South Korea (enrolling)
• Kangbuk Samsung Hospital — Seoul, South Korea (enrolling)
• Korea University Guro Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• SMG-SNU Boramae Medical Center — Seoul, South Korea (enrolling)
• Ajou University School of Medicine — Suwon, South Korea (enrolling)
• Uijeongbu St. Mary Hospital — Uijeongbu-si, South Korea (enrolling)

Full record on ClinicalTrials.gov

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