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NCT Number: NCT05050864

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

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

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Key information

Conditions

Pseudotumor Cerebri Brain Diseases Central Nervous System Diseases Cerebrospinal Fluid Intracranial Hypertension Nervous System Diseases Transverse Sinuses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation A De Rothschild

Paris, 75019, France

Location status: Recruiting

Location contact

Amélie YAVCHITZ

CONTACT

[email protected]

0148036454

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Resolution of the papillary edema

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Amélie Yavchitz, MD

CONTACT

[email protected]

(0)148036454 ext. +33

Pierre Bourdillon, MD

CONTACT

[email protected]

(0)148036862 ext. +33

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study 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

Acronym: HYDROPTIC

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2021
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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