Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

NCT ID: NCT05050864

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2026-12-07

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.

Conditions

Pseudotumor Cerebri; Cerebrospinal Fluid; Transverse Sinuses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

internal ventricular shunt (neurosurgery)

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

Group Type: ACTIVE_COMPARATOR

Neurosurgical internal ventricular shunt

Intervention Type: PROCEDURE

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)

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.

Group Type: ACTIVE_COMPARATOR

venous sinus stenting

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Bourdillon, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation A. de Rothschild

Locations

Fondation A De Rothschild

Paris, Paris, France

Site Status: RECRUITING

Countries

France

Central Contacts

Amélie Yavchitz, MD

Role: CONTACT

ayavachitz@for.paris

(0)148036454 ext. +33

Pierre Bourdillon, MD

Role: CONTACT

pbourdillon@for.paris

(0)148036862 ext. +33

Facility Contacts

Amélie YAVCHITZ

Role: primary

ayavchitz@for.paris

0148036454

Other Identifiers

PBN_2021_4

Identifier Type: -

Identifier Source: org_study_id