Assessment of coronary stent patency by photon counting CT

Assessment of coronary stent patency by photon counting CT - PCCT stent patency assessment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53948

Enrollment

138

Registered

2023-04-24

Start date

2022-12-30

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary stenoses

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Image quality score of the different reconstructions.	—

Countries

Netherlands

Outcome results