This Prospective Observational Study Aims to Evaluate the Capability of Ultra-high-resolution Photon-counting CT Angiography (UHR PCD-CTA) for Noninvasive Evaluation of Intracranial Venous Sinus Stents. The Study Will Compare Image Quality, Stent Visualization, Metal-related Artifacts, and Diagnosti

NCT07762677 | Recruiting

• 1 other identifier: PCD-CT venous Stent
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Intracranial Stenosis; Venous Sinus Stenosis; Stent Implantation; Intracranial Venous Pressures; Intracranial Venous Sinus Stenosis

Keywords

Photon-counting CT; Intracranial venous sinus stent; Ultra-high-resolution CT; CT angiography

Outcome Measures

Primary Outcomes (1)

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

  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.

  1-4 years

Secondary Outcomes (1)

• Signal-to-noise ratio on UHR PCD-CTA

  1-4years

Study Arms (1)

Patients With Intracranial Venous Sinus Stenosis

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic intracranial venous sinus stenosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xin Lou: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

• Xin Lou

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Jinhao Lyu, MD

CONTACT

+8615903562929; 330322990@qq.com

Jinying He

CONTACT

1527012389@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chairman

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): January 7, 2029
• Study Completion (Estimated): January 7, 2029
• Last Updated: August 20, 2026

Record last verified: 2026-08

Locations

CN (1)