Comparing stenting and neurosurgery for treating idiopathic intracranial hypertension
Official title: Randomized Controlled Trial Evaluating the Efficacy of Venous Sinus Stenting Versus Neurosurgical Internal Ventricular Shunt on Papillary Edema in the Management of Idiopathic Intracranial Hypertension
Run by Fondation Ophtalmologique Adolphe de Rothschild · NCT05050864 · Data updated 2026-11-12
This study is testing whether a shunt or stenting works better for people with idiopathic intracranial hypertension who haven't improved with medication, to see which one helps reduce swelling and improve vision.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 276 (estimated) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris, Paris) |
| Status | Recruiting |
| Started | March 2, 2022 |
| Main results expected | March 9, 2026 |
| Study ends | December 7, 2026 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT05050864 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and over with proven idiopathic intracranial hypertension and significant papillary edema who have not responded to medical treatment.
✕Probably not a fit
Patients with fulminant idiopathic intracranial hypertension or contraindications to the interventions will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness of two treatment options for idiopathic intracranial hypertension (HTICi), which causes increased intracranial pressure and can lead to vision loss. Participants will be assigned to receive either an internal ventricular shunt, which drains cerebrospinal fluid, or endovascular stenting, which aims to improve venous drainage from the brain. The study focuses on patients who have not responded to medical treatment and have specific imaging findings. The goal is to determine which intervention provides better outcomes in reducing papillary edema and improving visual function.
Why it matters
Potential benefit: If successful, this study could provide patients with more effective treatment options for managing idiopathic intracranial hypertension and preventing vision loss.
How similar studies have gone: Previous studies have shown that both neurosurgical and endovascular approaches can be effective, but this trial aims to directly compare their outcomes in a systematic way.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Fondation A De Rothschild
Paris, Paris, France Recruiting
Study contacts
- Principal investigator: Pierre Bourdillon, MD — Fondation A. de Rothschild
- Study coordinator: Amélie Yavchitz, MD
- Email: ayavachitz@for.paris
- Phone: (0)148036454
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.