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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Paclitaxel-eluting balloon

Treatment groups

400 Participants
are divided into 2 treatment groups