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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

Evaluation of Ultra-High-Resolution Photon-Counting CT Angiography for Intracranial Venous Sinus Stent Assessment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07762677
Enrollment
200
Registered
2026-08-13
Start date
2026-01-07
Completion date
2029-01-07
Last updated
2026-08-20

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

Conditions

Intracranial Stenosis, Intracranial Venous Pressures, Intracranial Venous Sinus Stenosis, Stent Implantation, Venous Sinus Stenosis

Keywords

Photon-counting CT, Intracranial venous sinus stent, Ultra-high-resolution CT, CT angiography

Brief 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).

Detailed description

Intracranial venous sinus stenting has become an important treatment option for patients with symptomatic venous sinus stenosis, particularly those with idiopathic intracranial hypertension. Accurate imaging follow-up after stent placement is essential for evaluating stent patency, recurrent stenosis, and potential complications such as in-stent thrombosis or occlusion. Conventional CT angiography (CTA) is commonly used for noninvasive follow-up after venous sinus stent implantation; however, accurate assessment of stented venous sinuses remains challenging due to metal-related artifacts. Blooming artifact caused by the high attenuation of metallic stent material may result in overestimation of stent thickness and obscuration of the stent lumen. In addition, beam-hardening artifacts from the stent and adjacent skull structures may further degrade image quality and reduce diagnostic confidence, potentially limiting the ability of CTA to detect clinically significant restenosis or thrombotic complications.

Interventions

None listed

Sponsors

Xin Lou
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Agreement between UHR PCD-CTA and DSA for intracranial venous sinus stent patency1-4 yearsAgreement 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.

Secondary

MeasureTime frameDescription
Signal-to-noise ratio on UHR PCD-CTA1-4yearsSignal-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.

Countries

China

Contacts

CONTACTJinhao Lyu, MD
330322990@qq.com+8615903562929
CONTACTJinying He
1527012389@qq.com
STUDY_CHAIRXin Lou

Chinese PLA General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026