Coronary Artery Disease, Coronary Disease, PCI, Stent Restenosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTPhoton-counting detector computed tomography (PCD-CT)
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.
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactEva Steinacher, MD
Outcome results
None listed