RecruitingNot ApplicableNCT06919744

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

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


Sponsor

University Hospital, Montpellier

Enrollment

114 participants

Start Date

Sep 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether placing a stent (a small tube to open a narrowed vein) in the brain can help people newly diagnosed with idiopathic intracranial hypertension (IIH) — a condition where pressure inside the skull is too high for no known reason. The stent would go in a vein called the transverse sinus to improve drainage. **You may be eligible if...** - You are 18 or older - You were diagnosed with IIH within the last 3 months - Brain imaging shows narrowing in a specific vein (transverse sinus) - You have eye-related symptoms of IIH, including swelling of the optic nerve (papilledema) - Your MRI is otherwise normal except for IIH-related findings **You may NOT be eligible if...** - Your IIH was diagnosed more than 3 months ago - You have damage to the light-sensitive cells in your eye (macular ganglion cell atrophy) - You are unable to attend all required study visits 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBest medical care

Acetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.

DEVICEIntervention (stenting)

Transverse venous sinus will be stented by neuro-radiological intervention


Locations(3)

CHU de Montpellier Hôpital Gui de Chauliac

Montpellier, France

CHU de REIMS

Reims, France

CHU de Toulouse

Toulouse, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06919744


Related Trials