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Photon-counting CT for Intracranial Stent Assessment

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07769814
Enrollment
200
Registered
2026-08-18
Start date
2026-01-07
Completion date
2029-01-07
Last updated
2026-08-18

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

Conditions

Intracranial Arterial Stenosis, Intracranial Atherosclerotic Disease (ICAD), Ischemic Stroke, Stent Restenosis

Keywords

Photon-counting CT, Ultra-high-resolution CT, In-stent restenosis, Intracranial stent, CT angiography

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Xin Lou
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 90 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of UHR PCD-CTA for detecting significant in-stent stenosis1-4yearsSensitivity 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

MeasureTime frameDescription
Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis1-4yearsDiagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis (≥50%), using DSA as the reference standard.

Countries

China

Contacts

CONTACTJinhao Lyu, MD
330322990@qq.com+8615903562929
CONTACTJinying He
1527012389@qq.com+8613854153820
STUDY_CHAIRXin Lou, MD.PhD

Chinese PLA General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 19, 2026