Drug-coated balloon versus medicine alone for fatty plaques in heart arteries
Tests a drug-coated balloon for fatty coronary plaques in adults with acute coronary syndrome.
Key facts
- Who runs it
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Where
- Amsterdam, NetherlandsSee the site
- Trial code
- Registry title
- Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 4 Nov 2025
- Expected to end
- Jan 2033
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Paclitaxel-eluting balloon
- Record updated
- 15 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with acute coronary syndrome who had a successful stent procedure (PCI). It tests whether a drug-coated balloon makes fatty plaques in the heart arteries less dangerous than medication alone.
- Age
- 18 years and older
- Sex
- All sexes can join.
- Disease stage
- Acute coronary syndrome, with a successful PCI of a native coronary artery or major side branch. At least 2 native coronary arteries must be open enough to be imaged, with a vessel diameter above 2 mm and below 6 mm.
- Earlier treatment
- A successful PCI of a native coronary artery or major side branch is needed.
Main reasons for not taking part
- Unstable circulation (cardiogenic shock, need for intubation or inotropes)
- Known allergy to paclitaxel
- Complications during the index PCI
- Known kidney problems (eGFR below 30 mL/min/1.73 m2)
- Contrast allergy where steroid and antihistamine premedication cannot be given
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Presenting with acute coronary syndrome (ACS)
- Successful PCI of a native coronary artery or major side branch
- At least 2 native coronary arteries are accessible for invasive coronary imaging; i.e. not totally occluded and >2 mm and <6 mm reference vessel diameter
Who cannot take part
- Known hypersensitivity to paclitaxel
- Hypersensitivity or allergy to contrast with inability to administer steroid and antihistamine premedication
- Presence of a comorbid condition with a life expectancy of less than one year
- Known renal insufficiency, i.e. eGFR <30 mL/min/1.73 m2
- Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes)
- Procedural complications of the index PCI
- Body weight >250 kg
- Subject belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write
Where in Netherlands
- Amsterdam UMCAmsterdam, NetherlandsContact: Tamara N. DijkstraTaking people
About the trial
What the trial wants to find out
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).
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intervention groupTreatment being tested
Drug-coated balloon treatment of non-culprit lipid-rich plaque on top of guideline-directed medical therapy
Treatment: Paclitaxel-eluting balloon
- Control groupNo study treatment, for comparison
Guideline-directed medical therapy alone
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques: A Randomized Controlled Trial
- Plain-language title
- Drug-coated balloon versus medicine alone for fatty plaques in heart arteriesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 15 January 2026