Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase

NCT06919744 | Recruiting

• 2 other identifiers: RECHMPL 23_04302024-A02444-43
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Keywords

Intracranial hypertension; papillary edema; stenting; transverse sinus vein; chronic headache; tinnitus

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (9)

• HIT-6 grading scale score

  3 and 12 months

• Monthly headache days

  3 and 12 months

• THI score

  3 and 12 months

• Visual field

  3 and 12 months

• Visual acuity

  3 and 12 months

Study Arms (2)

best medical care

ACTIVE COMPARATOR

Acetazolamide and recommended weight loss

Drug: Best medical care

Experimental (stenting, neuro-radiological intervention)

EXPERIMENTAL

Stenting of the tranverse sinus vein

Device: Intervention (stenting)

Interventions

Best medical care DRUG

Acetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.

Also known as: Acetazolamide, Weight loss

best medical care

Intervention (stenting) DEVICE

Transverse venous sinus will be stented by neuro-radiological intervention

Experimental (stenting, neuro-radiological intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Ministère de la Santé: collaborator

Study Sites (3)

CHU de Montpellier Hôpital Gui de Chauliac

Montpellier, 34295, France

RECRUITING

CHU de REIMS

Reims, 51092, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, 31000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Pseudotumor Cerebri; Intracranial Hypertension; Headache Disorders; Tinnitus

Interventions

Acetazolamide; Methods; Stents

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Investigative Techniques; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Anne DUCROS, MD, PhD

CONTACT

+33 467 339 469; a-ducros@chu-montpellier.fr

Fédérico CAGNAZZO, MD, PhD

CONTACT

+33 467 337 532; f-cagnazzo@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)