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Completed

NCT Number: NCT04765956

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC, location AMC

Amsterdam, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Drug-eluting balloon treatment

Device

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

Primary outcomes

  1. LCBImm4 difference of DEB-treated LRPs

    Time frame: 9 months

    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).

Secondary outcomes

  1. 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

  2. Rate of flow-limiting dissections necessitating bail-out stent implantation;

    Time frame: 9 months

  3. Rate of periprocedural myocardial infarction;

    Time frame: 9 months

  4. 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

  5. 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

  6. Additional IVUS + NIRS lesion characteristics: plaque volume

    Time frame: 9 months

  7. Additional IVUS + NIRS lesion characteristics: minimal lumen area

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: DEBuT-LRP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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