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Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05050864
Acronym
HYDROPTIC
Enrollment
276
Registered
2021-09-21
Start date
2022-03-02
Completion date
2026-12-07
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrospinal Fluid, Pseudotumor Cerebri, Transverse Sinuses

Keywords

Endovacascular, ventricular shunt, papillary edema, visual field

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.

Interventions

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

PROCEDURENeurosurgical 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

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resolution of the papillary edema3 months after the procedureResolution 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).

Countries

France

Contacts

Primary ContactAmélie Yavchitz, MD
ayavachitz@for.paris(0)148036454
Backup ContactPierre Bourdillon, MD
pbourdillon@for.paris(0)148036862

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026