drugset / Trial / NCT06945848

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

NCT06945848

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-01-05
Primary completion
2029-01-05
Completion
2030-01-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetazolamide Small molecule

Indications