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Recruiting Observational

This Prospective Observational Study Aims to Evaluate the Capability of Ultra-high-resolution Photon-counting CT Angiography (UHR PCD-CTA) for Noninvasive Evaluation of Intracranial Venous Sinus Stents. The Study Will Compare Image Quality, Stent Visualization, Metal-related Artifacts, and Diagnosti

NCT07762677 · tracked via the Priya Life Science China tracker
Sponsor
Phase
Observational
Started
2026-01-07
Last updated
2026-08-20

Condition(s) studied

Intracranial StenosisVenous Sinus StenosisStent ImplantationIntracranial Venous PressuresIntracranial Venous Sinus Stenosis

Study summary

This prospective observational study aims to evaluate the effectiveness of ultra-high-resolution photon-counting CT angiography (UHR PCD-CTA) for noninvasive assessment of intracranial venous sinus stents. The study will compare image quality, stent visualization, metal-related artifacts, and diagnostic accuracy between PCD-CTA and conventional energy-integrating detector CT angiography (EID-CTA).

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * Adults aged ≥18 years. * History of intracranial venous sinus stent implantation. * Undergoing follow-up contrast-enhanced CT angiography after stent -placement. * Available clinical and imaging data. Exclusion Criteria: * Severe motion artifacts affecting image interpretation. * Contraindication to iodinated contrast media. * Severe renal impairment preventing contrast-enhanced CT examination. * Incomplete imaging data. * Other conditions preventing reliable assessment of the venous sinus stent.

Primary outcome measure(s)

  • Agreement between UHR PCD-CTA and DSA for intracranial venous sinus stent patency — 1-4 years
    Agreement between ultra-high-resolution photon-counting detector CT angiography (UHR PCD-CTA) and digital subtraction angiography (DSA) for the assessment of intracranial venous sinus stent patency will be quantified using Cohen's kappa (κ) coefficient. Stent patency will be classified according to the predefined diagnostic criteria, with DSA serving as the reference standard.

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing Beijing Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07762677 on ClinicalTrials.gov ↗ ← All trials in China