Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

Cerebrospinal Fluid Clinical Trial

— HYDROPTIC  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050864
• Other study ID #: PBN_2021_4
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: March 15, 2027

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie Yavchitz, MD
• Phone: (0)148036454
• Email: ayavachitz[@]for.paris
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: March 15, 2027
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrospinal Fluid
• Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

Procedure:
• 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
• 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

Locations

Country	Name	City	State
France	Fondation A De Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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