CompletedNot Applicable

Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques

Netherlands45 participantsStarted 2021-01-19

Plain-language summary

Rationale: Two-thirds of intracoronary thrombi causing acute coronary syndrome (ACS) result from rupture of lipid-rich plaques (LRP). After treatment of the culprit lesion in ACS patients, additional LRPs are found in approximately 50% of patients. Near infrared spectroscopy (NIRS) combined with intracoronary ultrasound (IVUS) can identify these vulnerable plaques during coronary angiography (CAG) and is able to assess plaque characteristics and the lipid-core burden index in a 4mm segment (LCBImm4). It is currently unknown whether treatment of LRPs leads to plaque stabilization, potentially reducing the number of subsequent ACS. We hypothesize that LRPs can be treated with balloons coated with an antiproliferative drug (i.e. drug-eluting balloons; DEB) to deliver selective pharmacotherapeutic treatment to halt the local atherosclerotic process and subsequently reduce the risk for atherosclerotic events. Objectives: To determine the change in plaque characteristics of non-culprit LRPs, as measured with IVUS/NIRS, after treatment with DEB in patients with ACS. Study design: Prospective single-arm clinical trial Study population: Patients with non-ST-elevation acute coronary syndromes Intervention: If a LRP is detected with IVUS/NIRS, it will be treated with DEB. In case multiple LRPs are detected, only one will be treated. Main study endpoints: The difference in LCBImm4 between baseline and 9 months of plaques treated with DEB.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Previous coronary artery bypass-grafting;
. Presence of a chronic total occlusion;
. Too many (complex) coronary lesions requiring staged PCI procedure(s);
. Procedural complication of the index PCI;
. Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes);
. Patients with ST-segment elevations on the ECG requiring immediate primary PCI;
. Body weight \> 250 kg;
. Known renal insufficiency (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min/1.73m2 or subject on dialysis);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

LCBImm4 difference of DEB-treated LRPs

Timeframe: 9 months

Trial details

NCT IDNCT04765956

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-09

View on ClinicalTrials.gov More Coronary Artery Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Previous coronary artery bypass-grafting;
. Presence of a chronic total occlusion;
. Too many (complex) coronary lesions requiring staged PCI procedure(s);
. Procedural complication of the index PCI;
. Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes);
. Patients with ST-segment elevations on the ECG requiring immediate primary PCI;
. Body weight \> 250 kg;
. Known renal insufficiency (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min/1.73m2 or subject on dialysis);