NCT06919744

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

• 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 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.

Detailed description

The DIVE-IIN-EARLY trial is a multicenter randomized controlled trial designed to evaluate whether transverse venous sinus stenting is more effective than best medical therapy alone as first-line treatment for patients with idiopathic intracranial hypertension (IIH). The study targets patients with a new diagnosis of 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 gain). 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 to this disease. Usual medication for this condition is acetazolamide, but it's efficacy as well as it's tolerance is mostly poor. By proposing stenting in the early phase of the disease, one could avoid long term symptoms such as loss of vision and chronic headache.

Conditions

• Idiopathic Intracranial Hypertension (IIH)

Interventions

Type	Name	Description
DRUG	Best medical care	Acetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.
DEVICE	Intervention (stenting)	Transverse venous sinus will be stented by neuro-radiological intervention

Timeline

• Start date: 2025-09-19
• Primary completion: 2028-10-30
• Completion: 2029-04-30
• First posted: 2025-04-09
• Last updated: 2025-10-03

Locations

3 sites across 1 country: France