About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent
DES in proximal coronary vessel segments
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Photon-counting detector computed tomography (PCD-CT)
Diagnostic testPatients undergoing follow-up coronary angiography with IVI after percutaneous coronary intervention (PCI) as part of routine clinical practice will additionally receive coronary computed tomography angiography (CCTA) with PCD as part of this study.
Treatment groups
Trial outcomes
Primary outcomes
Quantitative comparison of PCD-CT and IVI in stent evaluation
Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization
Qualitative comparison of PCD-CT and IVI in stent evaluation
Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent)
Secondary outcomes
Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis
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
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
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)
Locations
Sponsors and contacts
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