Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06499207

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia PCI Stent Restenosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quantitative comparison of PCD-CT and IVI in stent evaluation

    Time frame: Within 1 year

    Comparison of post-PCI minimal stent area, stent diameter, stent lumen visualization, coronary wall visualization

  2. Qualitative comparison of PCD-CT and IVI in stent evaluation

    Time frame: Within 1 year

    Two experienced radiologists/cardiologists will independently rate image noise and stent artefacts (1 = inadequate; 5 = excellent)

Secondary outcomes

  1. Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis

    Time frame: 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

  2. Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology

    Time frame: Within 1 year

    Plaque morphology: Characterization of plaque components using Hounsfield units (HU) with the appropriate CCTA and IVI analysis software

  3. Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Steinacher, MD

CONTACT

[email protected]

004314040046140

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: ACDC

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 12, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.