RecruitingNot ApplicableNCT06945848

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

Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic INtracranial Hypertension Under Long-term Treatment With AceTazolamidE With Inadequate Treatment Response

Sponsor

University Hospital, Montpellier

Enrollment

114 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Idiopathic Intracranial Hypertension (IIH)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether placing a small stent (tube) inside a narrowed vein in the brain can help people with idiopathic intracranial hypertension (IIH) — a condition where pressure inside the skull is too high without an obvious cause — whose symptoms haven't improved after more than a year of medication. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of idiopathic intracranial hypertension (IIH) - You have been taking acetazolamide (a medication to lower brain pressure) for more than 1 year - Your brain pressure is still elevated (above 25 cmH2O) - You have a narrowing of the main draining vein of the brain (transverse sinus stenosis) confirmed on MRI **You may NOT be eligible if...** - Your high brain pressure has a known cause other than IIH - Your MRI shows abnormalities unrelated to IIH - You have conditions that make a vein procedure unsafe - You have not been on medication for IIH for at least a year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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