RECRUITINGINTERVENTIONAL

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

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (1)

Amsterdam UMC

Amsterdam, Netherlands