MedTrace Logo

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

NCT06945848 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Idiopathic Intracranial Hypertension (IIH)

Interventions

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

Sponsors & Collaborators

  • Direction Générale de l'Offre de Soins

    collaborator OTHER_GOV

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Vincent COSTALAT, MD, PhD · University hospital of Montpellier, FRANCE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-05
Primary Completion
2029-01-05
Completion
2030-01-05

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06945848 on ClinicalTrials.gov