NCT06954714 Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
| NCT ID | NCT06954714 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chonnam National University Hospital |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2027-12-31 |
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 256 participants in total. It began in 2025-08-18 with a primary completion date of 2027-12-31.
⚠ 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
This study aims to compare late-lumen loss (LLL) between DCB and DES to treat de novo coronary artery stenosis by intravascular ultrasound (IVUS).
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 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 ≥3.0 mm 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 \<1 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
Contact & Investigator
Young Joon Hong, MD, PhD
STUDY CHAIR
Chonnam National University
Frequently Asked Questions
Who can join the NCT06954714 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06954714 currently recruiting?
Yes, NCT06954714 is actively recruiting participants. Contact the research team at lsh8602@naver.com for enrollment information.
Where is the NCT06954714 trial being conducted?
This trial is being conducted at Busan, South Korea, Daegu, South Korea, Gwangju, South Korea, Jeonju, South Korea and 4 additional locations.
Who is sponsoring the NCT06954714 clinical trial?
NCT06954714 is sponsored by Chonnam National University Hospital. The principal investigator is Young Joon Hong, MD, PhD at Chonnam National University. The trial plans to enroll 256 participants.