Coronary Artery DiseaseDELETE-LRPNCT07107971
Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques
A study testing Paclitaxel-eluting balloon in people with Coronary Artery Disease and Atheroscleroses, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atheroscleroses, Cardiovascular Disease
- What is being tested?
- Paclitaxel-eluting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Nov 2025to Jan 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tamara N. Dijkstra, MD contact
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Tamara N. Dijkstra, +20 566 7883, t.n.dijkstra@amsterdamumc.nl
About this study
Official title: Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques: A Randomized Controlled Trial
The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries).
The main questions the study aims to answer are:
Read more
- Does the drug-coated balloon reduce the amount of fat inside the plaque more than medication alone?
- Is this treatment safe for patients?
Participants will:
- Undergo imaging of their coronary arteries during their planned heart procedure (PCI)
- Be randomly assigned to receive either a drug-coated balloon treatment or no extra treatment
- Undergo a heart scan (CT scan of the coronary arteries) within 2 weeks and again around 9 months after the procedure.
- Undergo a second heart catherization 9 months later to examine changes in the plaque.
Read the detailed description
Rationale:
Acute coronary syndromes (ACS) are often caused by rupture or erosion of certain high-risk vulnerable plaques. These plaques demonstrate specific features, such as a large lipid-rich necrotic core, a thin fibrous cap, and inflammation. Half of patients presenting with non-ST-segment elevation ACS have an additional vulnerable plaque, which increases their risk for non-culprit events during follow-up. Coronary intravascular ultrasound (IVUS) with the addition of near-infrared spectroscopy (NIRS) enables the identification of coronary lesions with high lipid content, quantified using the lipid-core burden index (LCBI) and is therefore able to distinguish plaques at risk to cause future non-culprit events. In addition, computed tomography coronary angiography (CCTA) is a non-invasive imaging modality that can identify high-risk plaque characteristics such as positive remodeling, low attentuation plaque, napkin-ring sign, and spotty calcification. Incorporating CCTA into this trial offers a unique opportunity to explore the potential of AI-based quantitative CT (AI-QCT) paramters by comparing them to IVUS-NIRS findings and clinical outcomes, which may support the future role of CCTA as a non-invasive tool for identifying and monitoring vulnerable plaques.
The main question remains whether local and systemic treatment of such high-risk plaques decreases the risk for adverse clinical outcome.
In our previous pilot study, DEBuT-LRP, we demonstrated that it was safe and feasible to treat vulnerable lipid-rich plaques with a drug-coated balloon (DCB) and that it was able to reduce the maximum LCBI on a 4 mm segment (maxLCBI4mm) after 9 months. In this randomized controlled trial, we intend to investigate the impact of DCB treatment on the maxLCBI4mm of lipid-rich plaques when compared to guideline-directed medical therapy alone.
Objective:
To test the hypothesis that paclitaxel-coated balloon treatment of non-obstructive non-culprit vulnerable lipid-rich plaques (LRP) leads to a greater reduction of the lipid-core burden index than guideline-directed medical therapy alone.
Study design:
A prospective two-arm randomized controlled trial.
Study population:
Patients older than 18 years with ACS who are scheduled for invasive percutaneous coronary intervention (PCI) of a native coronary artery.
Intervention:
DCB treatment of LRP in addition to guideline-directed medical therapy (GDMT).
Main study parameters:
The main study endpoint is the difference in maxLCBI4mm reduction from baseline to 9 months follow-up compared between the two randomization groups.
Secondary study endpoints are clinical safety endpoints (1. Flow-limiting dissection related to DCB-treatment necessitating bail-out stenting; 2. Periprocedural myocardial infarction; 3. Bleeding; 4. LRP lesion failure: cardiovascular death, myocardial infarction or repeat revascularization related to the index LRP, 5. Patient-oriented outcome: all-cause death, myocardial infarction or repeat revascularization) and imaging endpoints (1. IVUS-derived parameters; 2. QCA endpoints; 3. NIRS analyses of non-treated vessels; 4. CCTA-derived parameters).
- Conditions
- Coronary Artery Disease, Atheroscleroses, Cardiovascular Disease, Vulnerable Coronary Plaques, Vulnerable Plaque, Lipid-Rich Atherosclerosis of Coronary Artery
- Being tested
- Paclitaxel-eluting balloon
- Keywords
- Lipid-rich plaque, Vulnerable plaque, Near-infrared spectroscopy, Drug-coated balloon, Drug-eluting balloon, Paclitaxel-eluting balloon, Intravascular Ultrasound, Coronary computed tomography angiography, AI-QCT
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis, Cardiovascular Diseases, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-eluting balloonDevice
Participants in the intervention group will receive local treatment of non-obstructive, lipid-rich coronary plaques using a paclitaxel-coated drug-eluting balloon (DCB) in addition to guideline-directed medical therapy (GDMT). The DCB will be applied to plaques identified as high-risk based on near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) imaging, defined by a maxLCBI4mm ≥325. The balloon catheter diameter will be sized 1:1 according to the true lumen diameter as derived from IVUS. Balloon length will be sized to the LRP length as measured with IVUS including a 5 mm margin on each side. The balloon will be inflated at nominal pressure (6-8 ATM) during a period of at least 60 seconds, but preferably for 90 seconds if tolerated. A 5 mm margin is taken into account to differentiate between single or multiple LRPs within the same coronary artery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Drug-coated balloon treatment of non-culprit lipid-rich plaque on top of guideline-directed medical therapy Receives: Device: Paclitaxel-eluting balloon |
| Control group | No intervention | Guideline-directed medical therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in maxLCBI4mm of the target LRP
The mean difference in maxLCBI4mm of the target LRP between baseline and 9 month follow-up compared between the two randomization groups.
Measured: From baseline to 9 month follow-up.
Secondary outcomes (8)
Difference in maxLCBI4mm in non-treated LRPs
The change in maxLCBI4mm as measured with IVUS/NIRS from baseline to 9 month follow-up in identified additional LRPs that are not treated with DCB.
Measured: From baseline to 9 month follow-up.
The change in IVUS- and angiography-derived measurements
The change in IVUS- and angiography-derived measurements (plaque burden, minimal lumen area, mean plaque area, diameter stenosis and minimal lumen diameter) between baseline and 9 month follow-up.
Measured: From baseline to 9 month follow-up.
The change in CCTA-derived measurements
The change in CCTA-derived measurements using AI-QCT (total plaque volume, noncalcified plaque volume, calcified plaque volume, lumen volume and presence of the following high-risk plaque features: positive remodeling [remodeling index >1.1] and low-density plaque).
Measured: From baseline to 9 month follow-up.
Flow-limiting dissection necessitating bail-out stent implantation
Flow-limiting dissection necessitating bail-out stent implantation.
Measured: From baseline to 9 month follow-up.
Periprocedural myocardial infarction
Procedure-related myocardial infarction is defined according to the Fourth Universal Definition for Myocardial Infarction. Periprocedural myocardial infarction has occurred when an elevation of cTn values > 5 times of the 99th percentile URL in patients with normal baseline values is measured within a time window up to 48 hours post-procedure.
Patients with elevated pre-procedural cTn values, in whom the pre-procedural cTn level are stable (≤ 20% variation) or falling, must meet the criteria for a >5 or >10 fold increase and manifest a change from the baseline value of >20%. In addition with at least one of the following:
- New ischaemic ECG changes;
- Development of new pathological Q waves;
- Imaging evidence of loss of viable myocardium that is presumed to be new and in a pattern consistent with an ischaemic aetiology;
- Angiographic findings consistent with a procedural flow-limiting complication.
Measured: From baseline to 9 month follow-up.
Bleeding (BARC-3 and -5)
The occurence of BARC Type 3 or 5 bleeding events.
Measured: From baseline to 5 year follow-up.
LRP lesion failure
LRP lesion failure, defined as the occurence of cardiovascular death, myocardial infarction, or ischemia-driven revascularization related to an identified non-culprit LRP lesion.
Measured: From baseline to 5 year follow-up.
Patient-oriented composite outcome
Patient-oriented composite outcome, defined as the occurrence of all-cause mortality, myocardial infarction, or any repeat revascularization.
Measured: From baseline to 5 year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start4 Nov 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 400 patients with acute coronary syndrome will be enrolled and undergo NIRS-IVUS imaging. Based on prior studies, approximately 50% are expected to have lipid-rich plaques (defined as maxLCBI4mm ≥325). These 200 patients will be randomized 1:1 to receive either drug-coated balloon treatment plus guideline-directed medical therapy or guideline-directed medical therapy alone. The remaining patients without lipid-rich plaques will be followed in an observational cohort within the DELETE-LRP study for long-term clinical outcomes.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bimmer Claessen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Bimmer E.P.M. Claessen, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107971
- Sponsor's protocol ID
- NL-009200
- Acronym
- DELETE-LRP
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Eluting Balloon Treatment Versus Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07107971
- Acronym / sponsor ID
- DELETE-LRP / NL-009200
- Conditions
- Coronary Artery Disease, Atheroscleroses, Cardiovascular Disease, Vulnerable Coronary Plaques, Vulnerable Plaque, Lipid-Rich Atherosclerosis of Coronary Artery
- Keywords
- Lipid-rich plaque, Vulnerable plaque, Near-infrared spectroscopy, Drug-coated balloon, Drug-eluting balloon, Paclitaxel-eluting balloon, Intravascular Ultrasound, Coronary computed tomography angiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 6 Aug 2025 (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.
The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries).
The main questions the study aims to answer are:
- Does the drug-coated balloon reduce the amount of fat inside the plaque more than medication alone?
- Is this treatment safe for patients?
Participants will:
- Undergo imaging of their coronary arteries during their planned heart procedure (PCI)
- Be randomly assigned to receive either a drug-coated balloon treatment or no extra treatment
- Undergo a heart scan (CT scan of the coronary arteries) within 2 weeks and again around 9 months after the procedure.
- Undergo a second heart catherization 9 months later to examine changes in the plaque.
Detailed description
Rationale:
Acute coronary syndromes (ACS) are often caused by rupture or erosion of certain high-risk vulnerable plaques. These plaques demonstrate specific features, such as a large lipid-rich necrotic core, a thin fibrous cap, and inflammation. Half of patients presenting with non-ST-segment elevation ACS have an additional vulnerable plaque, which increases their risk for non-culprit events during follow-up. Coronary intravascular ultrasound (IVUS) with the addition of near-infrared spectroscopy (NIRS) enables the identification of coronary lesions with high lipid content, quantified using the lipid-core burden index (LCBI) and is therefore able to distinguish plaques at risk to cause future non-culprit events. In addition, computed tomography coronary angiography (CCTA) is a non-invasive imaging modality that can identify high-risk plaque characteristics such as positive remodeling, low attentuation plaque, napkin-ring sign, and spotty calcification. Incorporating CCTA into this trial offers a unique opportunity to explore the potential of AI-based quantitative CT (AI-QCT) paramters by comparing them to IVUS-NIRS findings and clinical outcomes, which may support the future role of CCTA as a non-invasive tool for identifying and monitoring vulnerable plaques.
The main question remains whether local and systemic treatment of such high-risk plaques decreases the risk for adverse clinical outcome.
In our previous pilot study, DEBuT-LRP, we demonstrated that it was safe and feasible to treat vulnerable lipid-rich plaques with a drug-coated balloon (DCB) and that it was able to reduce the maximum LCBI on a 4 mm segment (maxLCBI4mm) after 9 months. In this randomized controlled trial, we intend to investigate the impact of DCB treatment on the maxLCBI4mm of lipid-rich plaques when compared to guideline-directed medical therapy alone.
Objective:
To test the hypothesis that paclitaxel-coated balloon treatment of non-obstructive non-culprit vulnerable lipid-rich plaques (LRP) leads to a greater reduction of the lipid-core burden index than guideline-directed medical therapy alone.
Study design:
A prospective two-arm randomized controlled trial.
Study population:
Patients older than 18 years with ACS who are scheduled for invasive percutaneous coronary intervention (PCI) of a native coronary artery.
Intervention:
DCB treatment of LRP in addition to guideline-directed medical therapy (GDMT).
Main study parameters:
The main study endpoint is the difference in maxLCBI4mm reduction from baseline to 9 months follow-up compared between the two randomization groups.
Secondary study endpoints are clinical safety endpoints (1. Flow-limiting dissection related to DCB-treatment necessitating bail-out stenting; 2. Periprocedural myocardial infarction; 3. Bleeding; 4. LRP lesion failure: cardiovascular death, myocardial infarction or repeat revascularization related to the index LRP, 5. Patient-oriented outcome: all-cause death, myocardial infarction or repeat revascularization) and imaging endpoints (1. IVUS-derived parameters; 2. QCA endpoints; 3. NIRS analyses of non-treated vessels; 4. CCTA-derived parameters).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 400 patients with acute coronary syndrome will be enrolled and undergo NIRS-IVUS imaging. Based on prior studies, approximately 50% are expected to have lipid-rich plaques (defined as maxLCBI4mm ≥325). These 200 patients will be randomized 1:1 to receive either drug-coated balloon treatment plus guideline-directed medical therapy or guideline-directed medical therapy alone. The remaining patients without lipid-rich plaques will be followed in an observational cohort within the DELETE-LRP study for long-term clinical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Paclitaxel-eluting balloonDrug-coated balloon treatment of non-culprit lipid-rich plaque on top of guideline-directed medical therapy |
| Control group | No intervention | –Guideline-directed medical therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Paclitaxel-eluting balloonParticipants in the intervention group will receive local treatment of non-obstructive, lipid-rich coronary plaques using a paclitaxel-coated drug-eluting balloon (DCB) in addition to guideline-directed medical therapy (GDMT). The DCB will be applied to plaques identified as high-risk based on near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) imaging, defined by a maxLCBI4mm ≥325. The balloon catheter diameter will be sized 1:1 according to the true lumen diameter as derived from IVUS. Balloon length will be sized to the LRP length as measured with IVUS including a 5 mm margin on each side. The balloon will be inflated at nominal pressure (6-8 ATM) during a period of at least 60 seconds, but preferably for 90 seconds if tolerated. A 5 mm margin is taken into account to differentiate between single or multiple LRPs within the same coronary artery. | Device | Intervention group |
Primary outcome
Difference in maxLCBI4mm of the target LRP
Time frame: From baseline to 9 month follow-up.
The mean difference in maxLCBI4mm of the target LRP between baseline and 9 month follow-up compared between the two randomization groups.
8 secondary outcomes
Difference in maxLCBI4mm in non-treated LRPs
Time frame: From baseline to 9 month follow-up.
The change in IVUS- and angiography-derived measurements
Time frame: From baseline to 9 month follow-up.
The change in CCTA-derived measurements
Time frame: From baseline to 9 month follow-up.
Flow-limiting dissection necessitating bail-out stent implantation
Time frame: From baseline to 9 month follow-up.
Periprocedural myocardial infarction
Time frame: From baseline to 9 month follow-up.
Bleeding (BARC-3 and -5)
Time frame: From baseline to 5 year follow-up.
LRP lesion failure
Time frame: From baseline to 5 year follow-up.
Patient-oriented composite outcome
Time frame: From baseline to 5 year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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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.
Tamara N. Dijkstra, MD contact
Bimmer E.P.M. Claessen, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel-eluting balloon in people with Coronary Artery Disease and Atheroscleroses, 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 15 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bimmer E.P.M. Claessen, MD, PhD (+31 20 566 9111, b.e.claessen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in maxLCBI4mm of the target LRP (time frame: From baseline to 9 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2026.