Status:
RECRUITING
Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Ministère de la Santé
Conditions:
Idiopathic Intracranial Hypertension (IIH)
Eligibility:
All Genders
18+ years
Phase:
NA
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 sp...
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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)
- 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)
Key Trial Info
Start Date :
September 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06919744
Start Date
September 19 2025
End Date
April 30 2029
Last Update
October 3 2025
Active Locations (3)
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1
CHU de Montpellier Hôpital Gui de Chauliac
Montpellier, France, 34295
2
CHU de REIMS
Reims, France, 51092
3
CHU de Toulouse
Toulouse, France, 31000