Advanced Coronary Plaque Morphology Assessment Using Photon-counting Detection and Invasive Coronary Imaging
ACDC
1 other identifier
interventional
25
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable coronary-artery-disease
Started Nov 2024
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
November 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2026
ExpectedNovember 20, 2024
November 1, 2024
8 months
June 11, 2024
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Within 1 year
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)
Within 1 year
Secondary Outcomes (3)
Quantitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis
Within 1 year
Quantitative comparison of PCD-CT and IVI for the evaluation of plaque morphology
Within 1 year
Qualitative comparison of PCD-CT and IVI for the evaluation of in-stent restenosis and plaque morphology
Within 1 year
Interventions
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.
Eligibility Criteria
You may qualify if:
- Signed written informed consent
- DES in proximal coronary vessel segments
You may not qualify if:
- \- Any conditions that may interfere with the safety or efficacy of CCTA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 11, 2024
First Posted
July 12, 2024
Study Start
November 20, 2024
Primary Completion
July 15, 2025
Study Completion (Estimated)
July 15, 2026
Last Updated
November 20, 2024
Record last verified: 2024-11