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

NCT07107971 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Phase

Not applicable

Started

2025-11-04

Last updated

2026-01-15

Condition(s) studied

Coronary Artery DiseaseAtherosclerosesCardiovascular DiseaseVulnerable Coronary PlaquesVulnerable PlaqueLipid-Rich Atherosclerosis of Coronary ArteryAcute Coronary Syndromes (ACS)

Investigational drug(s) / intervention(s)

Paclitaxel-eluting balloon

Paclitaxel-eluting balloon: Participants in the intervention group will receive local treatment of non-obstructive, lipid-rich coronary plaques using a paclitaxel-coated drug-eluting balloon (DCB) in addition to guideline-directed medical therapy (GDMT). The DCB will be applied to plaques identified as high-risk based on near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) imaging, defined by a maxLCBI4mm ≥325. The balloon catheter diameter will be sized 1:1 according to the true lumen diameter as derived from IVUS. Balloon length will be sized to the LRP length as measured with IVUS including a 5 mm margin on each side. The balloon will be inflated at nominal pressure (6-8 ATM) during a period of at least 60 seconds, but preferably for 90 seconds if tolerated. A 5 mm margin is taken into account to differentiate between single or multiple LRPs within the same coronary artery.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * Hemodynamically unstable (presence of cardiogenic shock, need for intubation, need for inotropes); * Known hypersensitivity to paclitaxel; * Procedural complications of the index PCI; * Known renal insufficiency, i.e. eGFR \<30 mL/min/1.73 m2; * 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; * 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.

Primary outcome measure(s)

Difference in maxLCBI4mm of the target LRP — From baseline to 9 month follow-up.
The mean difference in maxLCBI4mm of the target LRP between baseline and 9 month follow-up compared between the two randomization groups.

Trial sites (1)

Facility	City	Region	Status
Amsterdam UMC	Amsterdam	Netherlands	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07107971 on ClinicalTrials.gov ↗ ← All trials in the Netherlands