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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat certain fatty buildups, called vulnerable plaques, in the heart’s arteries. These plaques can cause serious heart problems by blocking blood flow. The study wants to see if using a special balloon coated with medicine during a routine heart procedure can reduce the fat inside these plaques better than the usual medications alone. It will also check if this balloon treatment is safe for patients. The trial is for adults who are experiencing a recent heart problem caused by reduced blood flow, known as acute coronary syndrome.

People who might join this study need to be having this type of heart problem and must have had a successful procedure to open their arteries (called PCI). They also need to have at least two arteries that can be safely examined with imaging during the procedure. Participants will have pictures taken of their heart arteries during their procedure, then be randomly assigned to either get the drug-coated balloon treatment or just continue with standard medical care. Nine months later, they will have another imaging test to see how the plaques have changed. The study is not yet recruiting, and certain people—such as those who are very unstable, allergic to the medicine used on the balloon, or with serious kidney problems—will not be eligible. This trial aims to find better ways to protect the heart and prevent future problems by targeting these risky plaques more effectively.

Gender

ALL

Eligibility criteria

• 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.