Comparing drug-coated balloon angioplasty versus drug-eluting stents for new coronary artery blockages
Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions
This study will test whether drug-coated balloon angioplasty works as well as drug-eluting stents for adults with new coronary artery narrowings in vessels at least 3.0 mm wide.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chonnam National University Hospital Academic / other |
| Locations | 8 sites (Busan, Busan and 7 other locations) |
| Trial ID | NCT06954714 on ClinicalTrials.gov |
What this trial studies
Adults with de novo coronary artery stenosis in vessels ≥3.0 mm will receive either drug-coated balloon angioplasty or drug-eluting stent implantation, and artery changes will be measured using intravascular ultrasound (IVUS). The primary comparison is late-lumen loss (LLL) between the two approaches. The trial focuses on non-complex lesions eligible for percutaneous revascularization and records imaging and clinical outcomes over follow-up. The design compares a no-metal approach (DCB) that may allow shorter dual antiplatelet therapy against the current standard of a permanent metallic DES scaffold.
Who should consider this trial
Good fit: Adults aged 19 or older with at least one de novo coronary lesion causing >50% diameter stenosis (or FFR ≤0.80) in a vessel ≥3.0 mm who can give informed consent.
Not a fit: Patients with left main disease, in-stent restenosis, target lesions in bypass grafts, true bifurcation lesions requiring upfront two-stent techniques, known intolerance to antiplatelet therapy, cardiogenic shock, or life expectancy under one year are unlikely to benefit.
Why it matters
Potential benefit: If successful, drug-coated balloons could open arteries without leaving permanent metal behind and may allow shorter dual antiplatelet therapy, potentially lowering long-term stent-related risks.
How similar studies have performed: Prior randomized trials and meta-analyses support DCB use for in-stent restenosis and small-vessel de novo lesions, but results for larger or general de novo lesions have been mixed and non-inferiority to DES has not been consistently demonstrated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Busan, Busan and 7 other locations
- Kosin University Gospel Hospital — Busan, Busan, South Korea (Not_yet_recruiting)
- Keimyung University Dongsan Hospital — Daegu, Daegu, South Korea (Not_yet_recruiting)
- Chonnam National University — Gwangju, Gwangju, South Korea (Recruiting)
- Jeonbuk National University Hospital — Jeonju, Jeonju, South Korea (Not_yet_recruiting)
- Samsung Medical Center — Seoul, Seoul, South Korea (Not_yet_recruiting)
- Ewha Womans University Mokdong Hospital — Seoul, Seoul, South Korea (Not_yet_recruiting)
- Korea University Guro Hospital — Seoul, Seoul, South Korea (Not_yet_recruiting)
- Ulsan University Hospital — Ulsan, Ulsan, South Korea (Not_yet_recruiting)
Study contacts
- Study coordinator: Seung Hun Lee, MD, PhD
- Email: lsh8602@naver.com
- Phone: +82-62-220-6246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.