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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

19. august 2026 opdateret af: Xin Lou

Evaluation of Ultra-High-Resolution Photon-Counting CT Angiography for Intracranial Venous Sinus Stent Assessment

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).

Studieoversigt

Status

Rekruttering

Betingelser

Detaljeret beskrivelse

Intracranial venous sinus stenting has become an important treatment option for patients with symptomatic venous sinus stenosis, particularly those with idiopathic intracranial hypertension. Accurate imaging follow-up after stent placement is essential for evaluating stent patency, recurrent stenosis, and potential complications such as in-stent thrombosis or occlusion.

Conventional CT angiography (CTA) is commonly used for noninvasive follow-up after venous sinus stent implantation; however, accurate assessment of stented venous sinuses remains challenging due to metal-related artifacts. Blooming artifact caused by the high attenuation of metallic stent material may result in overestimation of stent thickness and obscuration of the stent lumen. In addition, beam-hardening artifacts from the stent and adjacent skull structures may further degrade image quality and reduce diagnostic confidence, potentially limiting the ability of CTA to detect clinically significant restenosis or thrombotic complications.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Jinhao Lyu, MD
Telefonnummer: +8615903562929
E-mail: 330322990@qq.com

Undersøgelse Kontakt Backup

Navn: Jinying He
E-mail: 1527012389@qq.com

Studiesteder

Kina
- Beijing Municipality
  - Beijing, Beijing Municipality, Kina, 100853
    - Rekruttering
    - Chinese PLA General Hospital
    - Kontakt:
      
      Jinhao Lyu, MD
      
      Telefonnummer: +8615903562929
      
      E-mail: 330322990@qq.com
    - Kontakt:
      
      Jinying He
      
      Telefonnummer: +8613854153820
      
      E-mail: 1527012389@qq.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients with symptomatic intracranial venous sinus stenosis

Beskrivelse

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
Patients With Intracranial Venous Sinus Stenosis Patients with symptomatic intracranial venous sinus stenosis who underwent CT angiography before and after venous sinus stent implantation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Agreement between UHR PCD-CTA and DSA for intracranial venous sinus stent patency Tidsramme: 1-4 years	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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Signal-to-noise ratio on UHR PCD-CTA Tidsramme: 1-4years	Signal-to-noise ratio (SNR) will be calculated using CT attenuation and image noise measurements obtained from predefined regions of interest on UHR PCD-CTA images.	1-4years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xin Lou

Efterforskere

Studiestol: Xin Lou, Chinese PLA General Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. januar 2026

Primær færdiggørelse (Anslået)

7. januar 2029

Studieafslutning (Anslået)

7. januar 2029

Datoer for studieregistrering

Først indsendt

8. august 2026

Først indsendt, der opfyldte QC-kriterier