Idiopathic Intracranial Hypertension (IIH)DIVE IIN EARLYNCT06919744
Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase
A study testing Best medical care and Intervention (stenting) in people with Idiopathic Intracranial Hypertension (IIH), run by University Hospital, Montpellier at 3 sites in France.
Trial summary
This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH)
- What is being tested?
- Best medical care and Intervention (stenting)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesFrance
- Study dates
- 19 Sep 2025to 30 Apr 2029
- 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
- Subject is ≥ 18 years old at inclusion.
- Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
- Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
- Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
- Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)
- Subject without macular ganglion cells atrophy seen on OCT
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- Patient having received information about data collection and having signed and dated an Informed Consent Form
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- Subjects must be covered by public health insurance
Who cannot join
- Subject previously treated with acetazolamide for IIH
- Known contrast product, Nickel, titanium allergy
- Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)
- History of intracranial venous thrombosis or intracranial neoplasia
- Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3/10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology and Mean Deficit of visual field superior to -10 dB
- Macular ganglion cells atrophy seen on OCT
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- Optic nerve atrophy
- Amblyopia
- Refractive error greater ±8 sphere or more than ±3 in cylinder in either eye if there are abnormalities in funduscopy (optic disc tilt, staphyloma), previous glaucoma, other disorders causing visual loss
- Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive
- Patient with a severe or fatal comorbidity that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
- Life expectancy under 6 months
- Chronic IIH
- Patients with renal failure (creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min, except if patient is already on hemodialysis)
- History of previously implanted intra-cranial sinus stent
- Previous gastric bypass surgery
- Contra-indication to general anesthesia
- Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant
- History of chronic obstructive pulmonary disease or other severe respiratory disease
- History of deep vein thrombosis or pulmonary embolism
- History of atrial fibrillation or other risks of stroke
- Cerebral vascular lesions (arteriovenous malformation, arteriovenous fistula, aneurysms, significant stenosis of extra- or intra-cranial vessels other than the targeted venous sinus stenosis, intracranial artery dissection, etc.).
- Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting
- Subject who are in a dependency or employment with the sponsor or the investigator
- Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
- Subject protected according to the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU de Montpellier Hôpital Gui de Chauliac
Montpellier, 34295
Anne DUCROS, MD, PhD, +33 467 339 469, a-ducros@chu-montpellier.fr
- Not yet recruiting
CHU de REIMS
Reims, 51092
Sébastien SOIZE, MD, PhD, +33 326 788 764, ssoize@chu-reims.fr
- Not yet recruiting
CHU de Toulouse
Toulouse, 31000
Guillaume BELLANGER, MD, PhD, +33 561 772 339, bellanger.g@chu-toulouse.fr
About this study
Official title: Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic INtracranial Hypertension in the Early Phase
This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.
Read the detailed description
The DIVE-IIN-EARLY trial is a multicenter randomized controlled trial designed to evaluate whether transverse venous sinus stenting is more effective than best medical therapy alone as first-line treatment for patients with idiopathic intracranial hypertension (IIH). The study targets patients with a new diagnosis of IIH with bilateral transverse sinus stenosis or unilateral stenosis of the dominant transverse sinus with a hypoplastic contralateral sinus.
Idiopathic intracranial hypertension is, in most cases, associated with narrowing of the transverse sinus vein, which may be the cause of increased intracranial blood pressure, resulting in the accumulation and increase in intracranial fluid pressure. This increased pressure is thought to be responsible for papilledema, chronic headaches, and tinnitus, among other symptoms.
Restoring a normal luminal diameter of the transverse sinus using a stent could therefore allow for the rapid restoration of normal intracranial pressures and an improvement in various symptoms.
Stent implantation in the transverse sinus is now part of standard care, but no large-scale clinical trial has formally established the superiority of the technique compared to the standard of care (drug therapy combined with weight gain). This study aims to provide evidence on the potential benefits of transverse venous sinus stenting as a treatment option for patients with idiopathic intracranial hypertension, which could significantly change the current management approach to this disease.
Usual medication for this condition is acetazolamide, but it's efficacy as well as it's tolerance is mostly poor. By proposing stenting in the early phase of the disease, one could avoid long term symptoms such as loss of vision and chronic headache.
- Being tested
- Best medical care, Intervention (stenting)
- Keywords
- Intracranial hypertension, papillary edema, stenting, transverse sinus vein, chronic headache, tinnitus
- Medical subject headings
- Pseudotumor Cerebri, Intracranial Hypertension, Headache Disorders, Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best medical careDrug
Also called Acetazolamide, Weight loss
Acetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.
Intervention (stenting)Device
Transverse venous sinus will be stented by neuro-radiological intervention
| Study group | Role | What they receive |
|---|---|---|
| best medical care | Active comparator | Acetazolamide and recommended weight loss Receives: Drug: Best medical care |
| Experimental (stenting, neuro-radiological intervention) | Experimental | Stenting of the tranverse sinus vein Receives: Device: Intervention (stenting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with resolved papilledema and normalization of intra-cranial pressure
Rate of patients with resolved papilledema (defined as Frisén scale grade 0-1 on OCT, without ganglion cells damage, and RNFL ˂ 130 µm) and normalization of intra-cranial pressure (defined as ≤ 25 cm H20 or 18 mmHg measured on lumbar puncture) at 3 months. Papilledema will be studied in the most affected eye.
Measured: 3 months
Secondary outcomes (9)
HIT-6 grading scale score
Change in mean HIT-6 grading scale score (patient's questionnaire containing 6 questions to evaluate the severity of headache)
Measured: 3 and 12 months
Monthly headache days
Change in monthly headache days (within the last month) reported on patients' dairy
Measured: 3 and 12 months
THI score
Change in THI (Tinnitus Handicap Inventory) score
Measured: 3 and 12 months
Visual field
Change in decibel of Mean Deficit visual field assessed on automated perimetry in both eyes with Humphrey Field Analyzer SITA Standard 24-2 test pattern. Each participant will have at least 2 initial visual field examinations conducted at least 30 minutes apart. The 2 Perimetric Mean Deviation (PMD) measurements will be averaged.
Measured: 3 and 12 months
Visual acuity
Change of visual acuity score evaluated on ETDRS (far vision) at 4 meters and reproducible lighting, and Parinaud scale (near vision) using the best optical correction
Measured: 3 and 12 months
Papilledema
Change of papilledema assessed on Frisen score and RNFL on OCT
Measured: 3 and 12 months
Patient's autonomy
Change in quality of life assessed on EQ5D questionnaire
Measured: 3 and 12 months
Patient's cognition
Change in Montreal Cognitive Assessment (MoCA)
Measured: 12 months
Cognition
Change in Trail Making Test (TMT) A and B
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start19 Sep 2025
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Ministère de la Santé
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919744
- Sponsor's protocol ID
- RECHMPL 23_0430
- Other IDs
- 2024-A02444-43
- Acronym
- DIVE IIN EARLY
- Status last verified
- Oct 2025
- First submitted
- 2 Apr 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic INtracranial Hypertension in the Early Phase
- ClinicalTrials.gov ID
- NCT06919744
- Acronym / sponsor ID
- DIVE IIN EARLY / RECHMPL 23_0430
- Keywords
- Intracranial hypertension, papillary edema, stenting, transverse sinus vein, chronic headache, tinnitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Ministère de la Santé
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 9 Apr 2025 (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.
This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.
Detailed description
The DIVE-IIN-EARLY trial is a multicenter randomized controlled trial designed to evaluate whether transverse venous sinus stenting is more effective than best medical therapy alone as first-line treatment for patients with idiopathic intracranial hypertension (IIH). The study targets patients with a new diagnosis of IIH with bilateral transverse sinus stenosis or unilateral stenosis of the dominant transverse sinus with a hypoplastic contralateral sinus.
Idiopathic intracranial hypertension is, in most cases, associated with narrowing of the transverse sinus vein, which may be the cause of increased intracranial blood pressure, resulting in the accumulation and increase in intracranial fluid pressure. This increased pressure is thought to be responsible for papilledema, chronic headaches, and tinnitus, among other symptoms.
Restoring a normal luminal diameter of the transverse sinus using a stent could therefore allow for the rapid restoration of normal intracranial pressures and an improvement in various symptoms.
Stent implantation in the transverse sinus is now part of standard care, but no large-scale clinical trial has formally established the superiority of the technique compared to the standard of care (drug therapy combined with weight gain). This study aims to provide evidence on the potential benefits of transverse venous sinus stenting as a treatment option for patients with idiopathic intracranial hypertension, which could significantly change the current management approach to this disease.
Usual medication for this condition is acetazolamide, but it's efficacy as well as it's tolerance is mostly poor. By proposing stenting in the early phase of the disease, one could avoid long term symptoms such as loss of vision and chronic headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| best medical care | Active comparator | Drug: Best medical careAcetazolamide and recommended weight loss |
| Experimental (stenting, neuro-radiological intervention) | Experimental | Device: Intervention (stenting)Stenting of the tranverse sinus vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is ≥ 18 years old at inclusion.
- Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
- Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
- Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
- Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)
Key exclusion criteria (27 listed)
- Subject previously treated with acetazolamide for IIH
- Known contrast product, Nickel, titanium allergy
- Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)
- History of intracranial venous thrombosis or intracranial neoplasia
- Fulminant decrease of visual acuity due to the IIH defined as a visual loss (of the most seriously impaired eye) of at least 3/10 (from corrected vision) within 4 weeks, in absence of any other ophthalmologic pathology and Mean Deficit of visual field superior to -10 dB
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 |
|---|---|---|
| Best medical careAlso: Acetazolamide, Weight lossAcetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended. | Drug | best medical care |
| Intervention (stenting)Transverse venous sinus will be stented by neuro-radiological intervention | Device | Experimental (stenting, neuro-radiological intervention) |
Primary outcome
Rate of patients with resolved papilledema and normalization of intra-cranial pressure
Time frame: 3 months
Rate of patients with resolved papilledema (defined as Frisén scale grade 0-1 on OCT, without ganglion cells damage, and RNFL ˂ 130 µm) and normalization of intra-cranial pressure (defined as ≤ 25 cm H20 or 18 mmHg measured on lumbar puncture) at 3 months. Papilledema will be studied in the most affected eye.
9 secondary outcomes
HIT-6 grading scale score
Time frame: 3 and 12 months
Monthly headache days
Time frame: 3 and 12 months
THI score
Time frame: 3 and 12 months
Visual field
Time frame: 3 and 12 months
Visual acuity
Time frame: 3 and 12 months
Papilledema
Time frame: 3 and 12 months
Patient's autonomy
Time frame: 3 and 12 months
Patient's cognition
Time frame: 12 months
Cognition
Time frame: 12 months
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 3 Oct 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best medical care and Intervention (stenting) in people with Idiopathic Intracranial Hypertension (IIH), run by University Hospital, Montpellier at 3 sites 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 9 inclusion and 27 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Anne DUCROS, MD, PhD (+33 467 339 469, a-ducros@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with resolved papilledema and normalization of intra-cranial pressure (time frame: 3 months). 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 3 Oct 2025.