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

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

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.

Conditions8

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