Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 second imaging procedure 9 months later to check changes in the plaque

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Contact Information
Primary
Bimmer E.P.M. Claessen, MD, PhD
b.e.claessen@amsterdamumc.nl
+31 20 566 9111
Backup
Tamara N. Dijkstra, MD
t.n.dijkstra@amsterdamumc.nl
Time Frame
Start Date: 2025-11-04
Estimated Completion Date: 2033-01
Participants
Target number of participants: 400
Treatments
Experimental: Intervention group
Drug-coated balloon treatment of non-culprit lipid-rich plaque on top of guideline-directed medical therapy
No_intervention: Control group
Guideline-directed medical therapy alone
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov