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
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Fondation A De Rothschild
RECRUITING
Paris
Contact Information
Primary
Amélie Yavchitz, MD
ayavachitz@for.paris
(0)148036454
Backup
Pierre Bourdillon, MD
pbourdillon@for.paris
(0)148036862
Time Frame
Start Date: 2022-03-02
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 276
Treatments
Active_comparator: 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
Active_comparator: 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.
Sponsors
Leads: Fondation Ophtalmologique Adolphe de Rothschild

This content was sourced from clinicaltrials.gov