Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide (NCT06945848) | Clinical Trial Compass
RecruitingNot Applicable
Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide
France114 participantsStarted 2026-01-05
Plain-language summary
This study is aimed at patients suffering from long term intracranial hypertension (caracterized by visual loss, chronic headache and/or tinnitus), receiving acetazolamide for more than 1 year, having inadequate response to treatment (untolerable side effects or insufficient efficacy).
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 care + 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 diagnosis of IIH satisfying the modified Dandy criteria (A to E) ) at the time of initial diagnosis, under BMM including ACZ for more than 1 year
✓. Patient with elevated intracranial pressure defined as \> 25 cm H20 or 18 mmHg
✓. 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
✓. 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
✓. Subjects must be covered by public health insurance
Exclusion criteria
✕. Patients receiving topiramate in the previous month
What they're measuring
1
Rate of patients with normalization of intra-cranial pressure
✕. Known contrast product, Nickel, titanium allergy
✕. Exposure to an oral drug (other than ACZ), 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
✕. Optic nerve atrophy
✕. Amblyopia
✕. Refractive error greater ±8 sphere or more than ±3 in cylinder in either eye if there are abnormalities in funduscopy (optic disc tilt, staphyloma), previous glaucoma, other disorders causing visual loss