Pseudotumor CerebriHYDROPTICNCT05050864
Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.
A study testing venous sinus stenting and Neurosurgical internal ventricular shunt in people with Pseudotumor Cerebri and Cerebrospinal Fluid, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses
- What is being tested?
- venous sinus stenting and Neurosurgical internal ventricular shunt
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2022to 7 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Fulminant HTICi
- Contraindication to antiplatelet aggregation
- Contraindication to one or the other of the interventions under study
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation A De Rothschild
Paris, Paris, 75019
Amélie YAVCHITZ, 0148036454, ayavchitz@for.paris
About this study
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
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.
Read more
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
Read the 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.
- Conditions
- Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses
- Being tested
- venous sinus stenting, Neurosurgical internal ventricular shunt
- Keywords
- Endovacascular, ventricular shunt, papillary edema, visual field
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venous sinus stentingProcedure or surgery
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 shuntProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| internal ventricular shunt (neurosurgery) | Active comparator | 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 Receives: Procedure: Neurosurgical internal ventricular shunt |
| endovacascular stenting (interventional neuroradiology) | Active comparator | 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. Receives: Procedure: venous sinus stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start2 Mar 2022
- Primary completion9 Mar 2026 (estimated)
- Study completion7 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudotumor CerebriStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Bourdillon, MD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050864
- Sponsor's protocol ID
- PBN_2021_4
- Acronym
- HYDROPTIC
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2021
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05050864
- Acronym / sponsor ID
- HYDROPTIC / PBN_2021_4
- Conditions
- Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses
- Keywords
- Endovacascular, ventricular shunt, papillary edema, visual field
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 9 Mar 2026 (estimated)
- Study completion
- 7 Dec 2026 (estimated)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| internal ventricular shunt (neurosurgery) | Active comparator | Procedure: Neurosurgical internal ventricular shuntThe 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 |
| endovacascular stenting (interventional neuroradiology) | Active comparator | Procedure: venous sinus stentingThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Fulminant HTICi
- Contraindication to antiplatelet aggregation
- Contraindication to one or the other of the interventions under study
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venous sinus stentingThe 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 | Procedure or surgery | endovacascular stenting (interventional neuroradiology) |
| Neurosurgical internal ventricular shuntThe 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 | Procedure or surgery | internal ventricular shunt (neurosurgery) |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre Bourdillon, MD principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venous sinus stenting and Neurosurgical internal ventricular shunt in people with Pseudotumor Cerebri and Cerebrospinal Fluid, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie Yavchitz, MD ((0)148036454 ext. +33, ayavachitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of the papillary edema (time frame: 3 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.