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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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 criteria

Qualifiers

Subject is ≥ 18 years old at inclusion.

Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)

Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI

Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities

Disqualifiers

Subject previously treated with acetazolamide for IIH

Known contrast product, Nickel, titanium allergy

Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)

History of intracranial venous thrombosis or intracranial neoplasia

Trial design

Treatments tested in this trial

  • Best medical care
  • Intervention (stenting)

Treatment groups

114 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

Ministère de la Santé

Collaborator