About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Subject previously treated with acetazolamide for IIH
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
Trial design
Treatments tested in this trial
- Best medical care
- Intervention (stenting)
Treatment groups
Sponsors and collaborators
University Hospital, Montpellier
Lead sponsor
Ministère de la Santé
Collaborator