Actively Recruiting
Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for Lipid-Rich Coronary Plaques: A Randomized Controlled Trial
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-01-15
400
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can reduce their risk compared to standard medication alone in adults with acute coronary syndrome (ACS). The study focuses on plaques with high fat content that may cause future heart problems. Researchers aim to find out if this treatment lowers the fat inside plaques more than medication and if it is safe. Participants are randomly assigned to one of two groups: one receives a paclitaxel-coated drug-eluting balloon treatment along with guideline-directed medical therapy, while the other group receives only the medical therapy. The balloon is sized and inflated in the affected artery segment during a planned heart procedure (PCI). The study includes imaging with near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) and computed tomography coronary angiography (CCTA) to assess plaque characteristics. Participants will undergo coronary artery imaging during their PCI, a heart CT scan within 2 weeks and again at about 9 months, and a follow-up heart catheterization 9 months later to check plaque changes. Researchers will measure changes in plaque fat content (maxLCBI4mm), safety events, and other imaging parameters. The study follows participants for up to 5 years to monitor clinical outcomes and safety.
CONDITIONS
Brief 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 coronary imaging with reference vessel diameter between 2 mm and 6 mm
You will not qualify if you...
- Hemodynamically unstable, including cardiogenic shock or need for intubation or inotropes
- Known hypersensitivity to paclitaxel
- Procedural complications during the index PCI
- Known renal insufficiency with eGFR less than 30 mL/min/1.73 m2
- Allergy to contrast media preventing steroid and antihistamine premedication
- Comorbid condition with life expectancy under one year
- Body weight exceeding 250 kg
- Belonging to a vulnerable population or unable to read or write
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months
Participants receive either drug-coated balloon treatment of non-culprit lipid-rich plaques in addition to guideline-directed medical therapy or guideline-directed medical therapy alone.
1 baseline visit and 1 follow-up visit at 9 months
Duration - Up to 5 years
Participants are monitored for safety and clinical outcomes including bleeding events, lesion failure, and patient-oriented outcomes.
Periodic visits during follow-up up to 5 years
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
B
Bimmer E.P.M. Claessen, MD, PhD
T
Tamara N. Dijkstra, MD
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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