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NCT Number: NCT07769814

Photon-counting CT for Intracranial Stent Assessment

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.

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Key information

Age range

5 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

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

Inclusion criteria

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

Exclusion criteria

  • Severe motion artifacts;
  • Poor contrast enhancement;
  • Incomplete clinical or imaging data.

Treatment and study plan

Primary outcomes

  1. Sensitivity of UHR PCD-CTA for detecting significant in-stent stenosis

    Time frame: 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.

Secondary outcomes

  1. Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis

    Time frame: 1-4years

    Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis (≥50%), using DSA as the reference standard.

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]

+8613854153820

Sponsors and collaborators

Lead sponsor

Xin Lou

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 18, 2026
Registry last updated
Aug 18, 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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