Comparing drug-coated balloon angioplasty versus drug-eluting stents for new coronary artery blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chonnam National University
  Gwangju, South Korea Recruiting
• Kosin University Gospel Hospital
  Busan, South Korea Not yet recruiting
• Keimyung University Dongsan Hospital
  Daegu, South Korea Not yet recruiting
• Jeonbuk National University Hospital
  Jeonju, South Korea Not yet recruiting
• Samsung Medical Center
  Seoul, South Korea Not yet recruiting
• Ewha Womans University Mokdong Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: Seung Hun Lee, MD, PhD
• Email: lsh8602@naver.com
• Phone: +82-62-220-6246

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.