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NCT Number: NCT07762677

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

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic agreement of UHR PCD-CTA with DSA for evaluation of intracranial venous sinus stent patency

    Time frame: 1-4 years

    The primary outcome is the agreement between ultra-high-resolution photon-counting CT angiography (UHR PCD-CTA) and digital subtraction angiography (DSA) for assessment of intracranial venous sinus stent patency.

Secondary outcomes

  1. Image Quality

    Time frame: 1-4years

    Image quality of photon-counting CT angiography images will be evaluated using both objective and subjective assessments.

Study contacts

Contact information is provided by the study sponsor or research team.

Jinhao Lyu, MD

CONTACT

[email protected]

+8615903562929

Jinying He

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xin Lou

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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