Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques

The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries). The main questions the study aims to answer are: * Does the drug-coated balloon reduce the amount of fat inside the plaque more than medication alone? * Is this treatment safe for patients? Participants will: * Undergo imaging of their coronary arteries during their planned heart procedure (PCI) * Be randomly assigned to receive either a drug-coated balloon treatment or no extra treatment * Undergo a heart scan (CT scan of the coronary arteries) within 2 weeks and again around 9 months after the procedure. * Undergo a second heart catherization 9 months later to examine changes in the plaque.

NCT Number	NCT07107971
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions	Coronary Artery Disease, Atheroscleroses, Cardiovascular Disease, Vulnerable Coronary Plaques, Vulnerable Plaque, Lipid-Rich Atherosclerosis of Coronary Artery, Acute Coronary Syndromes (ACS)
Enrollment	400 participants
Start Date	2025-11-04
Primary Completion	2028-01 (estimated)
Study Completion	2033-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-15