Assessment of coronary stent patency by photon counting CT

• Conditions: Coronary stenoses; artery narrowing; 10011082

• Registration Number: NL-OMON53948
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 138

Inclusion Criteria

- Age >= 18 years
- History of PCI with coronary stent placement
- Referred for clinically indicated non-emergent ICA

Exclusion Criteria

- Patient not meeting inclusion criteria
- (possible) pregnancy
- Concomitant or previous participation in a study that prohibits the patient
from participating in a study that exposes the patient to radiation
- eGFR <30 ml/min/1.73m2
- Allergy to iodinated contrast material
- Inability to provide informed consent

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the diagnostic performance, including sensitivity,<br /><br>specificity, positive predictive value (PPV), and negative predictive value<br /><br>(NPV), of the PCCT for determining luminal patency of the coronary stent with<br /><br>ICA as the reference standard.<br /><br><br /><br>Luminal patency is defined as no more than 50% loss of the in-stent vessel<br /><br>lumen diameter on ICA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Image quality score of the different reconstructions.</p><br>