CompletedNCT04765956DEBuT-LRPUpdated Jun 25, 2026

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

An interventional study of Drug-eluting balloon treatment in Coronary Artery Disease, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment

From the registry’s dates

Primary completion was Sep 2023, 3 years ago, and no results have been posted to the registry.

Phase: Not applicable
Study type: Interventional
Enrollment: 45
Allocation: Not applicable
Sex: All

Study 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.

Conditions studied

Coronary Artery Disease

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Keywords

Lipid-rich plaque
Non-ST-elevation myocardial infarction
Near-infrared spectroscopy
Drug-eluting balloon

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 45 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patient has an acute coronary syndrome without ST-segment elevation on the ECG (NSTE-ACS), including non-ST-elevation myocardial infarction and unstable angina pectoris, defined according to the Fourth Universal Definition of Myocardial Infarction.
An invasive revascularization strategy for NSTE-ACS with PCI is chosen.

Exclusion criteria

Exclusion Criteria:

- Angiographic 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;
- Clinical exclusion criteria:
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);
Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
Presence of a comorbid condition with a life expectancy of less than one year;
Participation in another trial;
Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 45 participants (actual)

Study arms

Experimental
Drug-eluting balloon treatment
Drug-eluting balloon (DEB) treatment of lipid-rich plaque
Device: Drug-eluting balloon treatment

Interventions

DeviceDrug-eluting balloon treatment
Drug-eluting balloon (DEB) treatment of lipid-rich plaque

What researchers measure

Primary outcomes

LCBImm4 difference of DEB-treated LRPs
The difference in LCBImm4 between baseline and 9 months follow-up of lipid-rich plaques treated with drug-eluting balloon, as measured with near-infrared spectroscopy (NIRS).
Time frame: 9 months

Secondary outcomes

The change in lipid-core burden index in a 4 mm segment (LCBImm4) as measured with IVUS + NIRS from baseline to 9 month follow-up in identified additional LRPs that are not treated with DEB.
Time frame: 9 months
Rate of flow-limiting dissections necessitating bail-out stent implantation;
Time frame: 9 months
Rate of periprocedural myocardial infarction;
Time frame: 9 months
Rate of LRP lesion failure (defined as cardiac death, myocardial infarction, or ischemia-driven revascularization related to an identified non-culprit LRP lesion up to one-year follow-up);
Time frame: 1 year
Patient-oriented composite outcomes, defined as all-cause mortality, myocardial infarction, or any repeat revascularization up to one-year follow-up;
Time frame: 1 year
Additional IVUS + NIRS lesion characteristics: plaque volume
Time frame: 9 months
Additional IVUS + NIRS lesion characteristics: minimal lumen area
Time frame: 9 months

Study locations

1 site

Amsterdam UMC, location AMC
Amsterdam, 1105AZ, Netherlands

References and documents

Publications

van Veelen A, Kucuk IT, Fuentes FH, Kahsay Y, Garcia-Garcia HM, Delewi R, Beijk MAM, den Hartog AW, Grundeken MJ, Vis MM, Henriques JPS, Claessen BEPM. First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study. J Clin Med. 2023 Sep 6;12(18):5807. doi: 10.3390/jcm12185807. PubMed 37762747 ↗
van Veelen A, Kucuk IT, Garcia-Garcia HM, Fuentes FH, Kahsay Y, Delewi R, Beijk MAM, den Hartog AW, Grundeken MJ, Vis MM, Henriques JPS, Claessen BEPM. Paclitaxel-coated balloons for vulnerable lipid-rich plaques. EuroIntervention. 2024 Jul 1;20(13):e826-e830. doi: 10.4244/EIJ-D-23-01073. No abstract available. PubMed 38949243 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04765956
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party: J.P.S Henriques (Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted: Feb 23, 2021
Start date: Jan 19, 2021
Primary completion: Sep 9, 2023
Completion: Sep 9, 2023
Last update: Jun 25, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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