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Not yet recruitingNCT06499207ACDCUpdated Nov 20, 2024

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

An interventional study of Photon-counting detector computed tomography (PCD-CT) in Coronary Artery Disease, Coronary Disease and PCI, sponsored by Medical University of Vienna. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Coronary Artery Disease
  • Coronary Disease
  • PCI
  • Stent Restenosis
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 25 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

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.

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06499207
Lead sponsor
Medical University of Vienna
Responsible party
Eva Steinacher (MD, Medical University of Vienna) — Principal investigator
First posted
Jul 12, 2024
Start date
Nov 20, 2024 (estimated)
Primary completion
Jul 15, 2025 (estimated)
Completion
Jul 15, 2026 (estimated)
Last update
Nov 20, 2024

Study contacts

Eva Steinacher, MD
Contact
eva.steinacher@meduniwien.ac.at
004314040046140

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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