Actively Recruiting
Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.
Led by Fondation Ophtalmologique Adolphe de Rothschild · Updated on 2026-01-05
276
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses and whose origin remains unknown. This hypertension can lead to papillary edema (OP) which can lead to a narrowing of the visual field and progress to blindness. Along with weight reduction, acetazolamide, which reduces the production of cerebrospinal fluid (CSF), is prescribed as a first-line treatment. Its efficacy is inconsistent in resolving papillary edema and there are many side effects. In the event of ineffectiveness or dependence on acetazolamide associated with hygiene and dietetic rules, a second line of therapy is then considered: neurosurgical (internal shunt of the LCS) or endovascular (venous stenting) treatment. These invasive techniques have each proven their effectiveness in the rapid and permanent resorption of OP, allowing improvement or preservation of visual function. In terms of induced morbidity, the superiority of one technique over the other, if it exists, has not been established. Our objective is to compare the efficacy, safety, and safety of LCS bypass surgery versus venous sinus stenting in HTICi with moderate to severe visual impairment after failure of medical treatment defined by the absence of resorption of the OP after several months
CONDITIONS
Official 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 proven with pressure greater than 25 cm of water
- Presence of papillary edema grade above 0 on the Frisen scale
- Stenosis of at least one transverse sinus confirmed by MRI
- Failure of medical treatment with surgical or interventional indication by the medical team
- Consent given 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 women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fondation A De Rothschild
Paris, Paris, France, 75019
Actively Recruiting
Research Team
A
Amélie Yavchitz, MD
CONTACT
P
Pierre Bourdillon, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here