Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension
Egypt40 participantsStarted 2025-03-01
Plain-language summary
This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema.
. No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis.
. Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities.
. No etiology for increased intracranial pressure: On neuroimaging findings.
Exclusion criteria
. Age less than or equal to 18 years.
. severe allergic reaction to iodine contrast or chronic Kidney disease.
. contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis
. patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
. pregnancy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in headache impact scale(HIT-6)
Timeframe: 3, 6 months
2
Papilledema Friesen grading scale
Timeframe: 3 months and 6 months
3
Visual filed Assessment Perimetry
Timeframe: 3,6 months
4
Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration