Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in … (NCT06919744) | Clinical Trial Compass
RecruitingNot Applicable
Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase
France114 participantsStarted 2025-09-19
Plain-language summary
This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is ≥ 18 years old at inclusion.
✓. Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
✓. Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
✓. Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
✓. Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)
✓. Subject without macular ganglion cells atrophy seen on OCT
✓. Patient having received information about data collection and having signed and dated an Informed Consent Form
✓. Subjects must be able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
✕. Subject previously treated with acetazolamide for IIH
What they're measuring
1
Rate of patients with resolved papilledema and normalization of intra-cranial pressure
✕. Known contrast product, Nickel, titanium allergy
✕. Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)
✕. History of intracranial venous thrombosis or intracranial neoplasia
✕. Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3/10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology and Mean Deficit of visual field superior to -10 dB