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

Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic INtracranial Hypertension Under Long-term Treatment With AceTazolamidE With Inadequate Treatment Response

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.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Montpellier (other)
• Locations: 3 sites (Montpellier and 2 other locations)
• Trial ID: NCT06945848 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter trial enrolls adults with IIH treated with acetazolamide for more than one year who have transverse sinus stenosis on MRI and elevated opening pressures. Participants are randomly assigned to best medical management (medication plus weight-loss support) or to the same medical care plus transverse sinus stenting (using devices such as Tentos 4F or Precise ProRX). Outcomes including intracranial pressure and symptoms like papilledema, chronic headache, and tinnitus are measured at 1, 3, and 12 months. The trial compares symptom and pressure changes between stenting plus medical care versus medical care alone to determine potential added benefit of the procedure.

Who should consider this trial

Good fit: Adults (≥18) with definite IIH per modified Dandy criteria who have been on acetazolamide >1 year, have elevated opening pressure and transverse sinus stenosis on MRI, and can attend scheduled follow-up visits are the intended participants.

Not a fit: Patients without transverse sinus narrowing or those with contraindications to stenting such as contrast or nickel/titanium allergy, recent topiramate use, or inability to undergo the procedure are unlikely to benefit.

Why it matters

Potential benefit: If successful, stenting may lower intracranial pressure more rapidly than medical therapy alone and reduce papilledema, chronic headache, and risk of vision loss.

How similar studies have performed: Case series and observational studies report symptomatic and pressure improvements after venous sinus stenting, but randomized controlled evidence is limited and this trial aims to fill that gap.

Eligibility criteria

Inclusion Criteria:

1. Subject is ≥ 18 years old at inclusion.
2. Subject with definite diagnosis of IIH satisfying the modified Dandy criteria (A to E) ) at the time of initial diagnosis, under BMM including ACZ for more than 1 year
3. Patient with elevated intracranial pressure defined as \> 25 cm H20 or 18 mmHg
4. Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
5. Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
6. Patient having received information about data collection and having signed and dated an Informed Consent Form
7. Subjects must be able to attend all scheduled visits and to comply with all trial procedures
8. Subjects must be covered by public health insurance

Exclusion Criteria:

1. Patients receiving topiramate in the previous month
2. Known contrast product, Nickel, titanium allergy
3. Exposure to an oral drug (other than ACZ), 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. Optic nerve atrophy
7. Amblyopia
8. 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
9. Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive
10. 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.
11. Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
12. Life expectancy under 6 months
13. Patients with renal failure (creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min, except if patient is already on hemodialysis)
14. History of previously implanted intra-cranial sinus stent
15. Previous gastric bypass surgery AAP-DGOS PHRC-N 22\_0175 CHU DE MONTPELLIER Pr Costalat Vincent/Pr Ducros Anne Version n°2.2 date 25/03/2025 Page 28 sur 63
16. Contra-indication to general anesthesia
17. Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant
18. History of chronic obstructive pulmonary disease or other severe respiratory disease
19. History of deep vein thrombosis or pulmonary embolism
20. History of atrial fibrillation or other risks of stroke
21. 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.).
22. Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting
23. Subject who are in a dependency or employment with the sponsor or the investigator
24. Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
25. 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: Vincent COSTALAT, MD, PhD

Conditions: Idiopathic Intracranial Hypertension, Intracranial hypertension, Papillary edema, Stenting, Transverse sinus vein, Chronic headache, Tinnitus