Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension. — HYDROPTIC  

Cerebrospinal Fluid Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Intervention 1 Name : internal ventricular shunt (neurosurgery)

Other name [facultatif] :

Description :

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.

Intervention 2 Name : endovacascular stenting (interventional neuroradiology)

Other name [facultatif] :

Description :

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. ;

Related Conditions & MeSH terms

• Cerebrospinal Fluid
• Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

• NCT number: NCT05050864
• Study type: Interventional
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie Yavchitz, MD
• Phone: (0)148036454
• Email: ayavachitz@for.paris
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Completion date: March 15, 2027