Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Not Applicable

Recruiting

• Conditions: Cerebrospinal Fluid; Transverse Sinuses; Pseudotumor Cerebri
• Interventions: Procedure: Neurosurgical internal ventricular shunt; Procedure: venous sinus stenting

• Registration Number: NCT05050864
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-21
• Study Start: 2022-03-02
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-11
• Primary Completion: 2027-01-15
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Patient aged 18 or over
• HTICi proven greater than 25cm of water
• Presence of papillary edema (grade> 0 on the Frisen scale)
• Stenosis of at least one transverse sinus on MRI
• Failure of medical treatment and surgical / interventional indication defined by the medical team taking care of the patient
• Consent to participate in the study

Exclusion Criteria

• Fulminant HTICi
• Contraindication to antiplatelet aggregation
• Contraindication to one or the other of the interventions under study
• Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
internal ventricular shunt (neurosurgery)	Neurosurgical 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
endovacascular stenting (interventional neuroradiology)	venous 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.

Primary Outcome Measures

Name	Time	Method
Resolution of the papillary edema	3 months after the procedure	Resolution of the papillary edema at 3 months defined by: disappearance of the edema (grade 0 on the Frisén scale) or reduction of at least 2 grades of the edema compared to baseline without deterioration of the visual field (Humphrey).

Trial Locations

Locations (1)

Fondation A De Rothschild; 🇫🇷 Paris, France