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Stent vs. shunt: which brain pressure fix saves sight best?

NCT ID NCT05050864

Disease control Sponsor: Fondation Ophtalmologique Adolphe de Rothschild Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two invasive procedures—venous sinus stenting and a neurosurgical shunt—for treating idiopathic intracranial hypertension, a condition that causes high pressure in the brain and can lead to vision loss. The trial will enroll 276 adults who have not improved with standard medication. The goal is to see which procedure better resolves swelling of the optic nerve and preserves vision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
venous sinus stent and neurosurgical internal ventricular shunt
What this could lead to
If this trial succeeds, it could show which procedure is safer and more effective at saving vision in people with idiopathic intracranial hypertension.
What could go wrong
This is a mid-stage trial with 276 people, so results may not apply to everyone. Both procedures carry risks like infection, bleeding, or device failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 276 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient aged 18 or over * HTICi proven greater than 25cm of water * Presence of papillary edema (grade\> 0 on the Frisen scale) * Stenosis of at least one transverse sinus on MRI * Failure of medical treatment and surgical / interventional indication defined by the medical team taking care of the patient * Consent to participate in the study Exclusion Criteria: * Fulminant HTICi * Contraindication to antiplatelet aggregation * Contraindication to one or the other of the interventions under study * Pregnant or breastfeeding woman

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Conditions

The condition(s) this trial relates to.

pseudotumor cerebri

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebrospinal fluid Pseudotumor cerebri Transverse sinuses

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondation A De Rothschild

    RECRUITING

    Paris, Paris, 75019, France

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