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

ConditionsIntracranial Stenosis Venous Sinus Stenosis Stent Implantation Intracranial Venous Pressures Intracranial Venous Sinus Stenosis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-90

SponsorXin Lou

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Severe motion artifacts affecting image interpretation.

Contraindication to iodinated contrast media.

Severe renal impairment preventing contrast-enhanced CT examination.

Incomplete imaging data.

Trial population

Patients with symptomatic intracranial venous sinus stenosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants

are grouped into 1 trial group

Group A: Patients With Intracranial Venous Sinus Stenosis

Trial outcomes

Primary outcomes

Agreement between UHR PCD-CTA and DSA for intracranial venous sinus stent patency

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.

Time frame

1-4 years

Secondary outcomes

Signal-to-noise ratio on UHR PCD-CTA

Signal-to-noise ratio (SNR) will be calculated using CT attenuation and image noise measurements obtained from predefined regions of interest on UHR PCD-CTA images.

Time frame

1-4years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xin Lou

Lead sponsor

Chinese PLA General Hospital

Sponsor institution

Source ClinicalTrials.gov

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