Late-lumen Changes After Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stents in De Novo Coronary Lesions

Launched by CHONNAM NATIONAL UNIVERSITY HOSPITAL · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatments for patients with coronary artery disease, specifically looking at how well they work over time. The trial compares a method called drug-coated balloon angioplasty (DCB) with another method known as drug-eluting stents (DES) to see which one leads to better outcomes in terms of reducing late-lumen loss (LLL), which is the narrowing of the artery after treatment. The study will use a special imaging technique called intravascular ultrasound (IVUS) to measure these changes.

To be eligible for this trial, participants need to be at least 19 years old and have a coronary artery that is significantly narrowed (more than 50%) or not functioning properly. They should also be able to understand the study and provide consent to participate. However, some individuals may not qualify, such as those with certain heart conditions, serious health issues, or those who are pregnant or breastfeeding. If you decide to take part, you can expect to receive treatment and regular follow-up to monitor your heart health. It's important to know that this trial is not yet recruiting participants, so there will be a future opportunity to join once it starts.

Gender

ALL

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