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

NCT07107971 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-01-15

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Bimmer E.P.M. Claessen, MD, PhD · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2028-01-31
Completion
2033-01-31
FDA Device
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07107971 on ClinicalTrials.gov