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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of Vienna

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 volunteers

Qualifiers

Signed written informed consent

DES in proximal coronary vessel segments

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
Within 1 year
2

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)

Time frame
Within 1 year

Secondary outcomes

1

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

Time frame
Within 1 year
2

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

Time frame
Within 1 year
3

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)

Time frame
Within 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: