Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

NCT05050864 | Recruiting

• 1 other identifier: PBN_2021_4
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

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

Conditions

Pseudotumor Cerebri; Cerebrospinal Fluid; Transverse Sinuses

Keywords

Endovacascular; ventricular shunt; papillary edema; visual field

Outcome Measures

Primary Outcomes (1)

• Resolution of the papillary edema

  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).

  3 months after the procedure

Study Arms (2)

internal ventricular shunt (neurosurgery)

ACTIVE COMPARATOR

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

Procedure: Neurosurgical internal ventricular shunt

endovacascular stenting (interventional neuroradiology)

ACTIVE COMPARATOR

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.

Procedure: venous sinus stenting

Interventions

venous sinus stenting 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

endovacascular stenting (interventional neuroradiology)

Neurosurgical internal ventricular shunt 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

internal ventricular shunt (neurosurgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation A De Rothschild

Paris, Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Pierre Bourdillon, MD

  Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Yavchitz, MD

CONTACT

(0)148036454; ayavachitz@for.paris

Pierre Bourdillon, MD

CONTACT

(0)148036862; pbourdillon@for.paris

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Name : internal ventricular shunt (neurosurgery) 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) 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 vscription : enous drainage from the brain to increase the absorption of cerebrospinal fluid

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 21, 2021
• Study Start: March 2, 2022
• Primary Completion: March 9, 2026
• Study Completion (Estimated): December 7, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)