Intracranial StenosisNCT07762677
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
An observational study of Intracranial Stenosis and Venous Sinus Stenosis, run by Xin Lou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intracranial Stenosis, Venous Sinus Stenosis, Stent Implantation
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2026to 7 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients with symptomatic intracranial venous sinus stenosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jinying He contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jinhao Lyu, MD, +8615903562929, 330322990@qq.com
Jinying He, +8613854153820, 1527012389@qq.com
About this study
Official title: 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).
Read the detailed description
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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Intracranial Venous Sinus Stenosis | Patients with symptomatic intracranial venous sinus stenosis who underwent CT angiography before and after venous sinus stent implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-4 years
Secondary outcomes (1)
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.
Measured: 1-4years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start7 Jan 2026
- Primary completion7 Jan 2029 (estimated)
- Study completion7 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Lou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762677
- Sponsor's protocol ID
- PCD-CT venous Stent
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultra-High-Resolution Photon-Counting CT Angiography for Intracranial Venous Sinus Stent Assessment
- ClinicalTrials.gov ID
- NCT07762677
- Acronym / sponsor ID
- PCD-CT venous Stent
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xin LouUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 7 Jan 2029 (estimated)
- Study completion
- 7 Jan 2029 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Intracranial Venous Sinus Stenosis | – | –Patients with symptomatic intracranial venous sinus stenosis who underwent CT angiography before and after venous sinus stent implantation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic intracranial venous sinus stenosis
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between UHR PCD-CTA and DSA for intracranial venous sinus stent patency
Time frame: 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 secondary outcome
Signal-to-noise ratio on UHR PCD-CTA
Time frame: 1-4years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jinying He contact
Xin Lou study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Stenosis and Venous Sinus Stenosis, run by Xin Lou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinhao Lyu, MD (+8615903562929, 330322990@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between UHR PCD-CTA and DSA for intracranial venous sinus stent patency (time frame: 1-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.