Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05050864

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

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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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Fondation A De Rothschild

Paris, Paris, France, 75019

Actively Recruiting

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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

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Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension. | DecenTrialz