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

NCT06919744 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

  • Idiopathic Intracranial Hypertension (IIH)

Interventions

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

Sponsors & Collaborators

  • Ministère de la Santé

    collaborator UNKNOWN

  • University Hospital, Montpellier

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-19
Primary Completion
2028-10-30
Completion
2029-04-30

Countries

  • France

Study Locations

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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 NCT06919744 on ClinicalTrials.gov