Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Location status: Recruiting
Location contact
Jinhao Lyu, MD
CONTACT
Jinying He
CONTACT
NCT Number: NCT07769814
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.
Interested in participating?
Request Info5 year–90 year
All sexes
Observational
Beijing, Beijing Municipality, 100853, China
Location status: Recruiting
Jinhao Lyu, MD
CONTACT
Jinying He
CONTACT
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1-4years
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
Diagnostic accuracy of UHR PCD-CTA for detecting significant in-stent stenosis (≥50%), using DSA as the reference standard.
Contact information is provided by the study sponsor or research team.
Jinhao Lyu, MD
CONTACT
Jinying He
CONTACT
Xin Lou
Other
Evaluation of Ultra-high Resolution Photon-counting CT Angiography for Intracranial Stent Assessment: A Prospective Diagnostic Study With Digital Subtraction Angiography as Reference Standard
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07562178
Brain Diseases, Cardiovascular Diseases
Hizume, Iwate, Japan
View Trial DetailsNCT04221984
Intracranial Atherosclerotic Disease (ICAD)
Los Angeles, California, United States
View Trial DetailsNCT01819597
Arterial Occlusive Diseases, Arteriosclerosis
Los Angeles, California, United States
View Trial DetailsNCT07098572
Brain Diseases, Cardiovascular Diseases
Hermagor, Carinthia, Austria
View Trial Details