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Photon-counting CT for Intracranial Stent Assessment

2026年8月12日 更新者:Xin Lou

Evaluation of Ultra-high Resolution Photon-counting CT Angiography for Intracranial Stent Assessment: A Prospective Diagnostic Study With Digital Subtraction Angiography as Reference Standard

Intracranial atherosclerotic disease is an important cause of ischemic stroke, and intracranial stent implantation is increasingly used for patients with severe stenotic lesions. Evaluation of stent patency and detection of in-stent restenosis are essential during follow-up. Digital subtraction angiography (DSA) remains the reference standard for intracranial stent assessment; however, it is an invasive procedure associated with potential complications and radiation exposure. Conventional CT angiography may be limited by stent-related artifacts, including blooming artifact and beam-hardening effects, which can impair accurate evaluation of the stent lumen.

研究概览

详细说明

Intracranial atherosclerotic stenosis is one of the major causes of ischemic stroke worldwide. Percutaneous transluminal angioplasty and stenting (PTAS) has been widely applied for selected patients with severe intracranial arterial stenosis. Long-term surveillance after stent implantation is important because in-stent restenosis, incomplete stent expansion, incomplete stent apposition, and other stent-related abnormalities may affect clinical outcomes.

Digital subtraction angiography (DSA) is currently considered the reference standard for evaluating intracranial stent patency. However, DSA is an invasive examination requiring arterial catheterization and carries risks including vascular complications and radiation exposure. Therefore, a reliable noninvasive imaging method for intracranial stent follow-up is clinically desirable. Conventional energy-integrating detector CT angiography (EID-CTA) may be limited in intracranial stent evaluation because of metal-related artifacts, particularly blooming artifact and beam-hardening effects.

Photon-counting detector CT (PCD-CT) represents a new generation of CT technology with improved spatial resolution, reduced electronic noise, and enhanced material separation capabilities. Ultra-high-resolution PCD-CT angiography may overcome limitations of conventional CTA and improve visualization of intracranial stent structures.

This prospective observational diagnostic study will include patients with intracranial arterial stents who undergo follow-up UHR PCD-CTA examinations. For patients who undergo DSA within a predefined interval, the findings of UHR PCD-CTA will be compared with DSA.

The results of this study may help determine the clinical value of UHR PCD-CTA as a noninvasive alternative or complementary imaging method for intracranial stent surveillance.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Jinhao Lyu, MD
  • 电话号码:+8615903562929
  • 邮箱:330322990@qq.com

研究联系人备份

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100853
        • 招聘中
        • Chinese PLA General Hospital
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不适用

取样方法

非概率样本

研究人群

Patients with intracranial arterial stents

描述

Inclusion Criteria:

  1. Age ≥18 years;
  2. Patients with previously implanted intracranial arterial stents;
  3. Undergoing follow-up CTA examination;
  4. Available imaging data for analysis.

Exclusion Criteria:

  1. Severe motion artifacts;
  2. Poor contrast enhancement;
  3. Incomplete clinical or imaging data.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Patients with intracranial arterial stents
Patients with previously implanted intracranial arterial stents who underwent follow-up ultra-high-resolution photon-counting CT angiography (UHR PCD-CTA) for evaluation of Stent patency and stent-related abnormalities.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Sensitivity of UHR PCD-CTA for detecting significant in-stent stenosis
大体时间:1-4years
Sensitivity of ultra-high-resolution photon-counting detector CT angiography (UHR PCD-CTA) for detecting significant in-stent stenosis (≥50%), using digital subtraction angiography (DSA) as the reference standard.
1-4years

次要结果测量

结果测量
措施说明
大体时间
Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis
大体时间:1-4years
Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis (≥50%), using DSA as the reference standard.
1-4years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 学习椅:Xin Lou, MD.PhD、Chinese PLA General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月7日

初级完成 (估计的)

2029年1月7日

研究完成 (估计的)

2029年1月7日

研究注册日期

首次提交

2026年8月8日

首先提交符合 QC 标准的

2026年8月12日

首次发布 (实际的)

2026年8月18日

研究记录更新

最后更新发布 (实际的)

2026年8月18日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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