Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients receiving topiramate in the previous month
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
Trial design
Treatments tested in this trial
- Acetazolamide
- Stent (Tentos 4F or Precise ProRX)
Treatment groups
114 Participants
are divided into 2 treatment groupsSponsors and collaborators
University Hospital, Montpellier
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Source ClinicalTrials.gov