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Study identifier: NCT05050864 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Condition: Pseudotumor Cerebri · Cerebrospinal Fluid · Transverse Sinuses  ·  Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

PhaseNA
Planned participants276
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Amélie Yavchitz, MD  ·  (0)148036454  ·  ayavachitz@for.paris

Pierre Bourdillon, MD  ·  (0)148036862  ·  pbourdillon@for.paris

Always discuss trial participation with your own doctor first.

Locations (1)

Fondation A De RothschildParis, Paris, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT05050864