Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05050864

Randomized Controlled Trial Comparing Venous Sinus Stenting and Neurosurgical Internal Ventricular Shunt for Papillary Edema in Idiopathic Intracranial Hypertension

Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2026-01-05

276

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying idiopathic intracranial hypertension (HTICi), a condition mostly affecting young adults, especially women, caused by increased pressure inside the skull. This pressure can lead to swelling of the optic nerve (papillary edema), which may narrow the visual field and risk blindness. The study aims to compare two treatments to see which is more effective and safe for patients with moderate to severe vision problems after standard medical treatment has failed. The trial compares two procedures: neurosurgical internal ventricular shunting and endovascular venous sinus stenting. The shunt involves placing a catheter with an adjustable valve to help drain cerebrospinal fluid outside the skull. The stenting procedure uses a vascular device to open narrowed brain veins and requires six months of antiplatelet medication to improve fluid drainage. Both methods aim to reduce papillary edema and protect vision. Participants will be monitored for the resolution of papillary edema three months after treatment. The study involves assessments including imaging and clinical evaluations to measure treatment effects on eye swelling and vision. Researchers will track safety and effectiveness throughout the study, which began in 2022 and will continue until late 2026. Participants must provide consent and meet specific health criteria to join.

CONDITIONS

Brief Title

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 or over
  • Idiopathic intracranial hypertension with pressure over 25 cm of water
  • Presence of papillary edema (grade greater than 0 on the Frisen scale)
  • Stenosis of at least one transverse sinus on MRI
  • Failure of medical treatment and surgical or interventional indication by medical team
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • Fulminant idiopathic intracranial hypertension
  • Contraindication to antiplatelet aggregation
  • Contraindication to either of the study interventions
  • Pregnant or breastfeeding woman

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Procedure day and immediate recovery period

Participants undergo either a neurosurgical internal ventricular shunt or venous sinus stenting procedure to improve cerebrospinal fluid absorption.

1 procedure visit (in-person) plus hospital recovery

Post-operative Follow-up

Duration - Up to 6 months after the procedure

Participants are monitored for recovery and treatment effects, including management of antiplatelet therapy for up to 6 months in the stenting group.

Multiple follow-up visits over 6 months

Trial Site Locations

Total: 1 location

1

Fondation A De Rothschild

Paris, Paris, France, 75019

Actively Recruiting

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Research Team

A

Amélie Yavchitz, MD

P

Pierre Bourdillon, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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