Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease; Coronary Disease; PCI; Stent Restenosis

• Registration Number: NCT06499207
• Lead Sponsor: Medical University of Vienna

Brief Summary

This clinical trial aims to compare non-invasive photon-counting detector computed tomography (PCD-CT) with invasive intravascular imaging (IVI) for post-interventional follow-up in patients with coronary artery disease (CAD).

Participants will undergo post-interventional follow-up using both PCD-CT and coronary angiography with IVI. Researchers will test qualitative and quantitative PCD-CT results for non-inferiority to IVI regarding stent evaluation and detection of in-stent restenosis and plaque morphology.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Study Start: 2024-11-20
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Signed written informed consent
• DES in proximal coronary vessel segments

Exclusion Criteria

• Any conditions that may interfere with the safety or efficacy of CCTA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Qualitative comparison of PCD-CT and IVI in stent evaluation	Within 1 year	Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent)
Quantitative comparison of PCD-CT and IVI in stent evaluation	Within 1 year	Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization

Secondary Outcome Measures

Name	Time	Method
Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis	Within 1 year	Severity of stenosis: Calculation of the percentage (%) of lumen diameter and lumen are stenosis with the appropriate CCTA and IVI analysis software
Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology	Within 1 year	Plaque morphology: Characterization of plaque components using Hounsfield units (HU) with the appropriate CCTA and IVI analysis software
Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology	Within 1 year	Two experienced radiologists/cardiologists will independently rate the visualization of in-stent restenosis and plaque morphology using a five-point scale (1 = inadequate; 5 = excellent)