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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photon-counting detector computed tomography (PCD-CT) | Diagnostic Test | Patients 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 year |
| 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) | Within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 1 year |
| Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology |
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Inclusion Criteria:
Exclusion Criteria:
- Any conditions that may interfere with the safety or efficacy of CCTA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Steinacher, MD | Contact | 004314040046140 | eva.steinacher@meduniwien.ac.at |
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Plaque morphology: Characterization of plaque components using Hounsfield units (HU) with the appropriate CCTA and IVI analysis software |
| Within 1 year |
| 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) | Within 1 year |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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