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Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension. (HYDROPTIC)

Primary Purpose

Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
venous sinus stenting
Neurosurgical internal ventricular shunt
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pseudotumor Cerebri focused on measuring Endovacascular, ventricular shunt, papillary edema, visual field

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fondation A De RothschildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

internal ventricular shunt (neurosurgery)

endovacascular stenting (interventional neuroradiology)

Arm 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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 10, 2021
Last Updated
July 10, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
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1. Study Identification

Unique Protocol Identification Number
NCT05050864
Brief Title
Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
January 15, 2027 (Anticipated)
Study Completion Date
March 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses
Keywords
Endovacascular, ventricular shunt, papillary edema, visual field

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
internal ventricular shunt (neurosurgery)
Arm Type
Active Comparator
Arm 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
Arm Title
endovacascular stenting (interventional neuroradiology)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
venous sinus stenting
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
Neurosurgical internal ventricular shunt
Intervention 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
Primary Outcome Measure Information:
Title
Resolution of the papillary edema
Description
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).
Time Frame
3 months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Yavchitz, MD
Phone
(0)148036454
Ext
+33
Email
ayavachitz@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Bourdillon, MD
Phone
(0)148036862
Ext
+33
Email
pbourdillon@for.paris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Bourdillon, MD
Organizational Affiliation
Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation A De Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie YAVCHITZ
Phone
0148036454
Email
ayavchitz@for.paris

12. IPD Sharing Statement

Learn more about this trial

Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.

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