Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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