Transverse sinus stenting for newly diagnosed idiopathic intracranial hypertension

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

This will test whether adding transverse venous sinus stenting to standard medical care helps adults with newly diagnosed idiopathic intracranial hypertension improve vision, headaches, or tinnitus.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Montpellier (Academic / other)
• Locations: 3 sites (Montpellier and 2 other locations)
• Trial ID: NCT06919744 on ClinicalTrials.gov

What this trial studies

This multicenter randomized trial enrolls adults with a new (<3 months) diagnosis of IIH and MRI evidence of dominant or bilateral transverse sinus stenosis. Participants are randomized to best medical care (recommended medication plus weight loss) or best medical care plus endovascular stenting of the transverse venous sinus, with follow-up visits at 1, 3, and 12 months. Outcomes include changes in intracranial pressure–related symptoms, ophthalmologic measures (optic nerve swelling and retinal nerve fiber layer), and imaging findings. The trial is conducted at university hospitals in Montpellier, Reims, and Toulouse in France.

Who should consider this trial

Good fit: Adults (≥18) with a definite recent (<3 months) diagnosis of IIH, MRI showing dominant or bilateral transverse sinus stenosis, ophthalmologic evidence of papilledema without macular ganglion cell atrophy, and the ability to attend scheduled visits are the ideal candidates.

Not a fit: Patients without transverse sinus stenosis, with longstanding IIH, prior acetazolamide treatment, significant optic nerve atrophy, or allergy to contrast/metal stent components are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, stenting could more quickly restore normal intracranial pressure and improve vision, headaches, and tinnitus compared with medical therapy alone.

How similar studies have performed: Transverse sinus stenting is performed in some centers and smaller observational series report symptomatic improvement, but no large randomized trial has definitively proven superiority over medical therapy.

Eligibility criteria

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)

Where this trial is running

Montpellier and 2 other locations

• CHU de Montpellier Hôpital Gui de Chauliac — Montpellier, France (Recruiting)
• CHU de REIMS — Reims, France (Not_yet_recruiting)
• CHU de Toulouse — Toulouse, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Anne DUCROS, MD, PhD

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