NCT06945848

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The DIVE-IIN-LATE trial is a multicenter randomized controlled trial designed to evaluate whether transverse sinus stenting is more effective than best medical therapy alone for patients with idiopathic intracranial hypertension (IIH) treated with acetazolamide for more than one year. The study targets patients diagnosed with IIH with bilateral transverse sinus stenosis or unilateral stenosis of the dominant transverse sinus with a hypoplastic contralateral sinus. Idiopathic intracranial hypertension is, in most cases, associated with narrowing of the transverse sinus vein, which may be the cause of increased intracranial blood pressure, resulting in the accumulation and increase in intracranial fluid pressure. This increased pressure is thought to be responsible for papilledema, chronic headaches, and tinnitus, among other symptoms. Restoring a normal luminal diameter of the transverse sinus using a stent could therefore allow for the rapid restoration of normal intracranial pressures and an improvement in various symptoms. Stent implantation in the transverse sinus is now part of standard care, but no large-scale clinical trial has formally established the superiority of the technique compared to the standard of care (drug therapy combined with weight loss). This study aims to provide evidence on the potential benefits of transverse venous sinus stenting as a treatment option for patients with idiopathic intracranial hypertension, which could significantly change the current management approach of this disease.

Conditions

• Idiopathic Intracranial Hypertension (IIH)

Interventions

Type	Name	Description
DRUG	Acetazolamide	Acetazolamide will be maintained and weight loss will be recommended
DEVICE	Stent (Tentos 4F or Precise ProRX)	Transverse venous sinus will be stented by neuroradiological intervention

Timeline

• Start date: 2026-01-05
• Primary completion: 2029-01-05
• Completion: 2030-01-05
• First posted: 2025-04-25
• Last updated: 2026-03-06

Locations

3 sites across 1 country: France