Clinical Trial

Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide

Study acronym: DIVEIINLATE
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-22.
Status change: Not Yet Recruiting → Recruiting 2026-03-05
Trial Details
NCT Number NCT06945848
Lead Sponsor University Hospital, Montpellier
Collaborators: Direction Générale de l'Offre de Soins
Conditions Idiopathic Intracranial Hypertension (IIH)
Enrollment 114 participants
Start Date 2026-01-05
Primary Completion 2029-01-05 (estimated)
Study Completion 2030-01-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-06