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

Not Applicable

Not yet recruiting

• Conditions: Idiopathic Intracranial Hypertension (IIH)
• Interventions: Drug: Best medical care; Device: Intervention (stenting)

• Registration Number: NCT06919744
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-04-30
• Primary Completion: 2028-10-30
• Study Completion: 2029-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Subject is ≥ 18 years old at inclusion.
2. Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
3. Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
4. Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
5. Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)
6. Subject without macular ganglion cells atrophy seen on OCT
7. Patient having received information about data collection and having signed and dated an Informed Consent Form
8. Subjects must be able to attend all scheduled visits and to comply with all trial procedures
9. Subjects must be covered by public health insurance

Exclusion Criteria

1. Subject previously treated with acetazolamide for IIH
2. Known contrast product, Nickel, titanium allergy
3. 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)
4. History of intracranial venous thrombosis or intracranial neoplasia
5. 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
6. Macular ganglion cells atrophy seen on OCT
7. Optic nerve atrophy
8. Amblyopia
9. 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
10. Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive
11. 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.
12. Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
13. Life expectancy under 6 months
14. Chronic IIH
15. Patients with renal failure (creatinine > 1.5 mg/dl and/or creatinine clearance < 60 mL/min, except if patient is already on hemodialysis)
16. History of previously implanted intra-cranial sinus stent
17. Previous gastric bypass surgery
18. Contra-indication to general anesthesia
19. Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant
20. History of chronic obstructive pulmonary disease or other severe respiratory disease
21. History of deep vein thrombosis or pulmonary embolism
22. History of atrial fibrillation or other risks of stroke
23. 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.).
24. Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting
25. Subject who are in a dependency or employment with the sponsor or the investigator
26. Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
27. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
best medical care	Best medical care	Acetazolamide and recommended weight loss
Experimental (stenting, neuro-radiological intervention)	Intervention (stenting)	Stenting of the tranverse sinus vein

Primary Outcome Measures

Name	Time	Method
Rate of patients with resolved papilledema and normalization of intra-cranial pressure	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.

Secondary Outcome Measures

Name	Time	Method
Visual acuity	3 and 12 months	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
Papilledema	3 and 12 months	Change of papilledema assessed on Frisen score and RNFL on OCT
Patient's autonomy	3 and 12 months	Change in quality of life assessed on EQ5D questionnaire
Cognition	12 months	Change in Trail Making Test (TMT) A and B
HIT-6 grading scale score	3 and 12 months	Change in mean HIT-6 grading scale score (patient's questionnaire containing 6 questions to evaluate the severity of headache)
Monthly headache days	3 and 12 months	Change in monthly headache days (within the last month) reported on patients' dairy
THI score	3 and 12 months	Change in THI (Tinnitus Handicap Inventory) score
Visual field	3 and 12 months	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.
Patient's cognition	12 months	Change in Montreal Cognitive Assessment (MoCA)

Trial Locations

Locations (3)

CHU de Montpellier Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

CHU de REIMS; 🇫🇷 Reims, France

CHU de Toulouse; 🇫🇷 Toulouse, France