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临床试验/NCT07762677
NCT07762677招募中不适用

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

Xin Lou1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年1月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Diagnostic agreement of UHR PCD-CTA with DSA for evaluation of intracranial venous sinus stent patency

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Patients With Intracranial Venous Sinus Stenosis

Patients with symptomatic intracranial venous sinus stenosis who underwent CT angiography before and after venous sinus stent implantation.

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

次要结局

  • Image Quality(1-4years)
  • Signal-to-noise ratio on UHR PCD-CTA(1-4years)

研究者

发起方
Xin Lou
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xin Lou

Chairman

Chinese PLA General Hospital

研究点 (1)

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