Coronary Evaluation And Guided Lesion Exploration Using Photon-counting CT and Intracoronary Imaging Techniques

Recruiting

• Conditions: Coronary Artery Disease; OCT Angiography; CT

• Registration Number: NCT07036770
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

This study evaluates the diagnostic accuracy and limitations of photon-counting computed tomography (PCCT) in characterizing coronary plaque, with comparisons to optical coherence tomography (OCT) and intravascular ultrasound (IVUS). The objective is to assess whether cardiac ultra-high resolution (UHR) PCCT -with its improved spatial resolution and superior soft tissue contrast relative to conventional CT- can serve as a reliable, non-invasive alternative for coronary plaque assessment and support clinical decision-making. A total of 100 patients with either acute or chronic coronary syndrome will be enrolled, including 40 individuals with suspected in-stent restenosis and 10 patients one year post-percutaneous coronary intervention (PCI) for chronic total occlusion (CTO). All participants will undergo invasive coronary angiography based on current European Society of Cardiology guidelines. Cardiac PCCT imaging will be conducted shortly before the angiographic procedure, accompanied by invasive OCT evaluation. Additionally, a subgroup of 10 patients will undergo both OCT and IVUS, allowing for direct comparison across imaging modalities. OCT, regarded as the gold standard for plaque characterization, offers near-histological resolution for identifying plaque features, while IVUS is particularly effective in evaluating plaque burden and volume.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-26
• Study Start: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2027-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of coronary PCCT angiography.	From PCCT until OCT run, completed within 72 hours.	Assessment of co-primary endpoints luminal area (mm²), stenosis grade (%) and plaque content (mm²) of coronary PCCT as compared to OCT imaging.

Secondary Outcome Measures

Name	Time	Method
High-risk plaque features.	From PCCT until OCT run, completed within 72 hours.	Correlation of high-risk features on coronary PCCT with OCT findings, including presence of TCFA, lipid-rich plaque, macrophages, spotty calcification, microvessels, cholesterol crystal and/or layered plaque.
Plaque volume.	From PCCT until IVUS run, completed within 72 hours.	Comparison between plaque volume on coronary PCCT and IVUS (mm³).
Coronary reconstruction algorithm.	From PCCT until OCT run, completed within 72 hours.	Analysis of coronary artery reconstruction algorithm with PCCT as compared to invasive coronary angiogram (minimal lumen area; mm²).

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium