Actively Recruiting
Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-01-15
400
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presenting with acute coronary syndrome (ACS)
- Successful PCI of a native coronary artery or major side branch
- At least 2 native coronary arteries accessible for invasive imaging, with 2 mm to less than 6 mm diameter
You will not qualify if you...
- Hemodynamically unstable (cardiogenic shock, need for intubation or inotropes)
- Known hypersensitivity to paclitaxel
- Procedural complications during the PCI
- Known renal insufficiency with eGFR less than 30 mL/min/1.73 m2
- Allergy to contrast with inability to take steroid and antihistamine premedication
- Comorbid condition with life expectancy under one year
- Body weight over 250 kg
- Vulnerable population or unable to read or write as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
B
Bimmer E.P.M. Claessen, MD, PhD
CONTACT
T
Tamara N. Dijkstra, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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