Drug-coated balloon treatment versus medication for fat-rich coronary plaques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults presenting with acute coronary syndrome who undergo successful PCI will receive intravascular imaging (IVUS with NIRS) to identify lipid-rich plaques and then be randomly assigned to receive a paclitaxel-eluting balloon treatment at the vulnerable plaque or no additional local treatment in addition to guideline-directed medical therapy. Non-invasive CCTA will be performed within two weeks and again at about nine months, and invasive coronary imaging will be repeated at nine months to measure changes in lipid burden (LCBI) and plaque characteristics. The primary outcomes focus on change in lipid-core burden index and safety of the drug-coated balloon approach. Imaging comparisons will also explore AI-quantified CT parameters against IVUS-NIRS findings to evaluate noninvasive monitoring strategies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Bimmer E.P.M. Claessen, MD, PhD — Amsterdam UMC
• Study coordinator: Bimmer E.P.M. Claessen, MD, PhD
• Email: b.e.claessen@amsterdamumc.nl
• Phone: +31 20 566 9111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.