An observational study in Intracranial Stenosis, Venous Sinus Stenosis and Stent Implantation, sponsored by Xin Lou. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Xin Lou · Observational
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).
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.
456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.
This study's planned enrollment of 200 is above the median of 84 across 144 observational studies indexed under Constriction, Pathologic.
Browse Constriction, Pathologic studies →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.
Patients with symptomatic intracranial venous sinus stenosis
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Patients with symptomatic intracranial venous sinus stenosis who underwent CT angiography before and after venous sinus stent implantation.
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.
Time frame: 1-4 years
Signal-to-noise ratio on UHR PCD-CTA
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.
Time frame: 1-4years
Started Jan 2026 (actual). Primary completion is estimated for Jan 2029, 36 months after the start.
Of 52 non-industry observational studies under Constriction, Pathologic, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 62. This study's planned 36 months is above that.
Counting every sponsor, half of 64 studies reached it within 31 months; a quarter within 19 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
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Xin Lou