RecruitingNot ApplicableNCT05050864

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

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


Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Enrollment

276 participants

Start Date

Mar 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for idiopathic intracranial hypertension (IIH) — a condition where pressure inside the skull is too high without an obvious cause. It compares placing a stent in a narrowed brain vein (venous sinus stenting) versus a surgical procedure to relieve pressure, to see which works better. **You may be eligible if...** - You are 18 or older with confirmed high pressure inside the skull (above 25 cm of water) - You have optic nerve swelling (papilledema) on eye examination - An MRI shows narrowing of at least one brain vein (transverse sinus) - Medical treatments have already failed and your care team recommends an intervention **You may NOT be eligible if...** - You have a sudden, rapidly worsening form of the condition - You cannot take blood thinners or antiplatelet medications - You are pregnant or breastfeeding - You have contraindications to either surgical procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREvenous sinus stenting

The placement of a vascular endoprosthesis (stent) is an interventional neuroradiology procedure aimed, by venous approach (percutaneous puncture), to restore the diameter of a venous sinus. It requires 6 months of antiplatelet aggregation. The aim is to allow better venous drainage from the brain to increase the absorption of cerebrospinal fluid

PROCEDURENeurosurgical internal ventricular shunt

The internal ventricular shunt consists of the introduction of a catheter from a lateral ventricle into the atrium or peritoneum. It is associated with a valve whose opening pressure is adjustable. The goal is that cerebrospinal fluid can be absorbed extra-cranial


Locations(1)

Fondation A De Rothschild

Paris, Paris, France

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NCT05050864


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