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Clinical Trials in Egypt / NCT06833424
Starting soon Not applicable

Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension

NCT06833424 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Not applicable
Started
2025-03-01
Last updated
2025-02-18

Condition(s) studied

Idiopathic Intracranial Hypertension (IIH)

Investigational drug(s) / intervention(s)

Dural venous sinus stenting

Dural venous sinus stenting: 40 patients with idiopathic intracranial hypertension according to Modified Dandy Criteria will subjected to Dural venous stenting

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 40 Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH). 1. Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema. 2. No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis. 3. Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities. 4. No etiology for increased intracranial pressure: On neuroimaging findings. * Age: 18-60 years * Gender: Male or Female Inclusion Criteria. Exclusion Criteria 1. Age less than or equal to 18 years. 2. severe allergic reaction to iodine contrast or chronic Kidney disease. 3. contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis 4. patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. 5. pregnancy.

Primary outcome measure(s)

  • change in headache impact scale(HIT-6) — 3, 6 months
    The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function. minimum score 36 and maximum score 78
  • Papilledema Friesen grading scale — 3 months and 6 months
    The Frisen grading system is an objective criteria used to describe the degree of papilledema, which is swelling of the optic disc from increased ICP grading from zero to 5
  • Visual filed Assessment Perimetry — 3,6 months
    Perimetry is the systematic measurement of visual field function (the total area where objects can be seen in the peripheral vision while the eye is focused on a central point).
  • Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration — 3,6 months
    changes in other symptomology including tinnitus ,abducent nerve palsyand TVO

Trial sites (1)

FacilityCityRegionStatus
Faculty of Medicine Asyut Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833424 on ClinicalTrials.gov ↗ ← All trials in Egypt