Actively Recruiting
Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension Under Long-term Acetazolamide Treatment With Inadequate Response
Led by University Hospital, Montpellier · Updated on 2026-03-06
114
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
D
Direction Générale de l'Offre de Soins
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating idiopathic intracranial hypertension (IIH), a condition marked by increased pressure in the brain causing symptoms like visual loss, chronic headache, and tinnitus. The study focuses on patients who have been treated with acetazolamide for more than one year but continue to have symptoms or intolerable side effects. The goal is to determine if placing a stent in a specific brain vein, called the transverse sinus, can reduce this pressure and improve symptoms compared to standard medical care alone. Participants will be randomly assigned to one of two groups. One group will receive best medical care, which includes acetazolamide and recommended weight loss. The other group will receive the same medical care plus a stent placed in the transverse sinus vein through a neuroradiological procedure. The study includes follow-up visits at 1, 3, and 12 months to assess outcomes. During the study, participants will undergo evaluations including intracranial pressure measurement, headache frequency and severity, tinnitus, visual acuity and field, papilledema (optic swelling), and cognitive and autonomy assessments. Researchers will monitor how many patients achieve normalized intracranial pressure after three months. The study aims to provide detailed data on symptom changes and medication discontinuation, with a total participation period of at least one year.
CONDITIONS
Brief Title
Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at inclusion
- Definite diagnosis of idiopathic intracranial hypertension (IIH) meeting modified Dandy criteria
- Treated with acetazolamide for more than 1 year
- Elevated intracranial pressure defined as > 25 cm H20 or 18 mmHg
- Intracranial transverse venous sinus stenosis on dominant side with hypoplastic contralateral sinus or bilateral stenosis confirmed by MRI
- Normal MRI except for venous sinus stenosis or IIH-related abnormalities
- Provided informed consent
- Able to attend all scheduled visits and comply with trial procedures
- Covered by public health insurance
You will not qualify if you...
- Use of topiramate in the previous month
- Known allergy to contrast agents, nickel, or titanium
- Use of drugs or substances associated with increased intracranial pressure within 2 months before diagnosis (e.g., lithium, vitamin A, tetracycline)
- History of intracranial venous thrombosis or brain tumors
- Rapid visual loss defined as loss of at least 3/10 vision in the worse eye within 4 weeks
- Optic nerve atrophy or amblyopia
- Significant refractive errors with fundus abnormalities or previous glaucoma
- Positive pregnancy test if of childbearing potential
- Severe or fatal comorbidities preventing improvement or follow-up
- Evidence of intracranial hemorrhage
- Life expectancy under 6 months
- Renal failure with creatinine > 1.5 mg/dl or clearance < 60 mL/min unless on hemodialysis
- Previous intracranial sinus stent implantation
- Previous gastric bypass surgery
- Contraindications to general anesthesia or certain antiplatelet medications
- History of severe respiratory disease, deep vein thrombosis, pulmonary embolism, or atrial fibrillation
- Cerebral vascular lesions preventing safe stenting
- Anatomical anomalies preventing catheterization or stenting
- Employment or dependency on the sponsor or investigator
- Participation in another clinical trial or unapproved drug use within 4 weeks before screening
- Protected subjects under French Public Health Code (e.g., prisoners, pregnant or lactating women, under guardianship)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive either transverse venous sinus stenting or continue acetazolamide treatment with recommended weight loss to manage idiopathic intracranial hypertension.
Multiple visits during treatment period
Duration - Up to 12 months
Participants are monitored for outcomes including intracranial pressure normalization, headache, tinnitus, visual function, papilledema, and cognition up to 12 months after treatment.
Visits at 3 and 12 months post-treatment
Trial Site Locations
Total: 3 locations
1
CHU de Montpellier Hôpital Gui de Chauliac
Montpellier, France, 34295
Actively Recruiting
2
CHU de Reims
Reims, France, 51092
Not Yet Recruiting
3
CHU de Toulouse
Toulouse, France, 31000
Not Yet Recruiting
Research Team
V
Vincent COSTALAT, MD, PhD
F
Fédérico CAGNAZZO, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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