Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques

NCT07107971 | Recruiting DMC FDA Device

• 1 other identifier: NL-009200
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Disease; Atheroscleroses; Cardiovascular Disease; Vulnerable Coronary Plaques; Vulnerable Plaque; Lipid-Rich Atherosclerosis of Coronary Artery; Acute Coronary Syndromes (ACS)

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 9 month follow-up.

Secondary Outcomes (8)

• Difference in maxLCBI4mm in non-treated LRPs

  From baseline to 9 month follow-up.

• The change in IVUS- and angiography-derived measurements

  From baseline to 9 month follow-up.

• The change in CCTA-derived measurements

  From baseline to 9 month follow-up.

• Flow-limiting dissection necessitating bail-out stent implantation

  From baseline to 9 month follow-up.

• Periprocedural myocardial infarction

  From baseline to 9 month follow-up.

Study Arms (2)

Intervention group

EXPERIMENTAL

Drug-coated balloon treatment of non-culprit lipid-rich plaque on top of guideline-directed medical therapy

Device: Paclitaxel-eluting balloon

Control group

NO INTERVENTION

Guideline-directed medical therapy alone

Interventions

Paclitaxel-eluting balloon DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis; Cardiovascular Diseases; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bimmer E.P.M. Claessen, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bimmer E.P.M. Claessen, MD, PhD

CONTACT

+31 20 566 9111; b.e.claessen@amsterdamumc.nl

Tamara N. Dijkstra, MD

CONTACT

t.n.dijkstra@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist, Department of Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 6, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2033
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

NL (1)