- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07769814
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
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Jinhao Lyu, MD
- Telefonnummer: +8615903562929
- E-mail: 330322990@qq.com
Undersøgelse Kontakt Backup
- Navn: Jinying He
- Telefonnummer: +8613854153820
- E-mail: 1527012389@qq.com
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100853
- Rekruttering
- Chinese PLA General Hospital
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Kontakt:
- Jinhao Lyu, MD
- Telefonnummer: +8615903562929
- E-mail: 330322990@qq.com
-
Kontakt:
- Jinying He
- Telefonnummer: +8613854153820
- E-mail: 1527012389@qq.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Sensitivity of UHR PCD-CTA for detecting significant in-stent stenosis
Tidsramme: 1-4years
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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.
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1-4years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis
Tidsramme: 1-4years
|
Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis (≥50%), using DSA as the reference standard.
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1-4years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Xin Lou, MD.PhD, Chinese PLA General Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PCD-CT Artery Stent
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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