Coronary Artery DiseaseDEBuT-LRPNCT04765956
Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
A study testing Drug-eluting balloon treatment in people with Coronary Artery Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Drug-eluting balloon treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jan 2021to 9 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Coronary Artery Disease
- Being tested
- Drug-eluting balloon treatment
- Keywords
- Lipid-rich plaque, Non-ST-elevation myocardial infarction, Near-infrared spectroscopy, Drug-eluting balloon
- Medical subject headings
- Coronary Artery Disease, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting balloon treatmentDevice
Drug-eluting balloon (DEB) treatment of lipid-rich plaque
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting balloon treatment | Experimental | Drug-eluting balloon (DEB) treatment of lipid-rich plaque Receives: Device: Drug-eluting balloon treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 months
Secondary outcomes (7)
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.
Measured: 9 months
Rate of flow-limiting dissections necessitating bail-out stent implantation;
Measured: 9 months
Rate of periprocedural myocardial infarction;
Measured: 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);
Measured: 1 year
Patient-oriented composite outcomes, defined as all-cause mortality, myocardial infarction, or any repeat revascularization up to one-year follow-up;
Measured: 1 year
Additional IVUS + NIRS lesion characteristics: plaque volume
Measured: 9 months
Additional IVUS + NIRS lesion characteristics: minimal lumen area
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start19 Jan 2021
- Primary completion9 Sep 2023
- Study completion9 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.P.S Henriques, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765956
- Sponsor's protocol ID
- DEBuT-LRP
- Acronym
- DEBuT-LRP
- Status last verified
- Jun 2026
- First submitted
- 18 Feb 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 37762747van 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Identification and Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques
- ClinicalTrials.gov ID
- NCT04765956
- Acronym / sponsor ID
- DEBuT-LRP / DEBuT-LRP
- Conditions
- Coronary Artery Disease
- Keywords
- Lipid-rich plaque, Non-ST-elevation myocardial infarction, Near-infrared spectroscopy, Drug-eluting balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 9 Sep 2023 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting balloon treatment | Experimental | Device: Drug-eluting balloon treatmentDrug-eluting balloon (DEB) treatment of lipid-rich plaque |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug-eluting balloon treatmentDrug-eluting balloon (DEB) treatment of lipid-rich plaque | Device | Drug-eluting balloon treatment |
Primary outcome
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).
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 37762747van 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.
- Results publication: PubMed 38949243van 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.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-eluting balloon treatment in people with Coronary Artery Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LCBImm4 difference of DEB-treated LRPs (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765956, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.