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Not yet recruiting NCT06499207

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

No phase Interventional Coronary Artery Disease Coronary Disease PCI Stent Restenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photon-counting detector computed tomography (PCD-CT).
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Coronary Disease, PCI, Stent Restenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 test Photon-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.

Primary outcome measures

  • Quantitative comparison of PCD-CT and IVI in stent evaluation [Time frame: Within 1 year]
  • Qualitative comparison of PCD-CT and IVI in stent evaluation [Time frame: Within 1 year]
Secondary outcome measures (3)
  • Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis [Time frame: Within 1 year]
  • Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology [Time frame: Within 1 year]
  • Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology [Time frame: Within 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06499207 · ACDC_2547

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗