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RecruitingNCT07769814Updated Aug 18, 2026

Photon-counting CT for Intracranial Stent Assessment

An observational study in Intracranial Atherosclerotic Disease (ICAD), Intracranial Arterial Stenosis and Stent Restenosis, sponsored by Xin Lou. Recruiting at 1 site in China. Open to participants aged 5 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Xin Lou · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
5 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Photon-counting CT
  • Ultra-high-resolution CT
  • In-stent restenosis
  • Intracranial stent
  • CT angiography
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 200 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Xin Lou is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with intracranial arterial stents

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Severe motion artifacts;
  2. Poor contrast enhancement;
  3. Incomplete clinical or imaging data.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
4 Years
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 1-4years

Secondary outcomes

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

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

    Time frame: 1-4years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jan 2029, 36 months after the start.

Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 36 months is below that.

Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2026
First posted
Aug 18, 2026
StartActual
Jan 7, 2026
Primary completionEst.
Jan 7, 2029
CompletionEst.
Jan 7, 2029
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07769814
Lead sponsor
Xin Lou
Responsible party
Xin Lou (Chairman, Chinese PLA General Hospital) — Sponsor-investigator
First posted
Aug 18, 2026
Start date
Jan 7, 2026
Primary completion
Jan 7, 2029 (estimated)
Completion
Jan 7, 2029 (estimated)
Last update
Aug 18, 2026

Study contacts

Jinhao Lyu, MD
Contact
330322990@qq.com
+8615903562929
Jinying He
Contact
1527012389@qq.com
+8613854153820
Xin Lou, MD.PhD
study chair · Chinese PLA General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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