NCT04765956

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Drug-eluting balloon treatment	Drug-eluting balloon (DEB) treatment of lipid-rich plaque

Timeline

• Start date: 2021-01-19
• Primary completion: 2023-09-09
• Completion: 2023-09-09
• First posted: 2021-02-23
• Last updated: 2023-02-01

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study