Transverse sinus stenting for newly diagnosed idiopathic intracranial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: a-ducros@chu-montpellier.fr
• Phone: +33 467 339 469

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tirzepatide for Idiopathic Intracranial Hypertension

  This trial tests whether tirzepatide can help people with idiopathic intracranial hypertension by comparing it to placebo over 12 months.

  Recruiting Phase 4 Duke University · Durham, North Carolina · NCT07191873

• Advanced imaging techniques for understanding idiopathic intracranial hypertension

  This study is testing advanced imaging techniques on patients with stubborn idiopathic intracranial hypertension to see how stenting affects their brain fluid flow and overall condition.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT06950099

• Transverse sinus stenting for people with long-term intracranial hypertension on acetazolamide

  This trial will test whether adding a stent in the narrowed transverse sinus helps adults with idiopathic intracranial hypertension who have been on acetazolamide for over a year but still have symptoms.

  Recruiting University Hospital, Montpellier · Montpellier and 2 other locations · NCT06945848

• Understanding the link between body mass index and treatment response in idiopathic intracranial hypertension

  This study is trying to see how body weight affects treatment success in people with idiopathic intracranial hypertension and what weight goals might help them feel better.

  Recruiting University of Valencia · Valencia, Valencia · NCT06913712

• Comparing CSF shunts and dural venous sinus stents for IIH

  This will test whether a CSF shunt or a dural venous sinus stent better reduces pressure and preserves vision in adults with IIH who have severe papilloedema and are at risk of vision loss.

  Recruiting at 13 sites University of Birmingham · Birmingham and 14 other locations · NCT07440277

• Evaluating eye images to assess brain pressure

  This study is testing a new way to see if eye images can help tell if someone has high pressure in their brain, using a non-invasive method that could be safer than current techniques.

  Recruiting King's College Hospital NHS Trust · London, London · NCT06855342

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.