Clinical Trial

Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase

Study acronym: DIVE IIN EARLY
Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-02.
Status change: Not Yet Recruiting → Recruiting 2025-10-02
Trial Details
NCT Number NCT06919744
Lead Sponsor University Hospital, Montpellier
Collaborators: Ministère de la Santé
Conditions Idiopathic Intracranial Hypertension (IIH)
Enrollment 114 participants
Start Date 2025-09-19
Primary Completion 2028-10-30 (estimated)
Study Completion 2029-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-10-03