NCT06742931 Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
| NCT ID | NCT06742931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Chronic Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,200 participants in total. It began in 2025-04-07 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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 chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty 4. 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 5. 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. 6. 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. Exclusion Criteria: 1. Patients unable to provide consent 2. Patients with acute myocardial infarction or unstable angina 3. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB 4. Patients with indication of oral anticoagulant 5. Patients with concomitant drug-eluting stent implantation during index PCI 6. Patients with history of ischemic stroke or previous myocardial infarction 7. Patients with peripheral arterial occlusive disease 8. 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) 9. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year 10. Patients who may result in protocol non-compliance (site investigator's medical judgment) 11. Patients with cardiogenic shock or cardiac arrest 12. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 13. Patients with severe valvular heart disease requiring open heart surgery 14. Pregnant or lactating women
Contact & Investigator
Joo-Yong Hahn, MD, PhD
STUDY CHAIR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT06742931 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Chronic Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06742931 currently recruiting?
Yes, NCT06742931 is actively recruiting participants. Contact the research team at drone80@hanmail.net for enrollment information.
Where is the NCT06742931 trial being conducted?
This trial is being conducted at Ansan, South Korea, Daegu, South Korea, Gangneung, South Korea, Goyang, South Korea and 11 additional locations.
Who is sponsoring the NCT06742931 clinical trial?
NCT06742931 is sponsored by Samsung Medical Center. The principal investigator is Joo-Yong Hahn, MD, PhD at Samsung Medical Center. The trial plans to enroll 1,200 participants.