Actively Recruiting
Direct Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase
Led by University Hospital, Montpellier · Updated on 2025-10-03
114
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Montpellier
Lead Sponsor
M
Ministère de la Santé
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients recently diagnosed with idiopathic intracranial hypertension (IIH), a condition marked by increased pressure inside the skull that causes symptoms like vision loss, chronic headaches, and ringing in the ears. This trial aims to determine whether placing a stent in a narrowed vein in the brain can better reduce this pressure and improve symptoms compared to standard medical care alone. The study involves patients with specific vein narrowing diagnosed within the last three months. Participants will be randomly assigned to one of two groups: one receiving best medical care, which includes medication called acetazolamide and recommended weight loss; and the other receiving the same medical care plus a stenting procedure in the transverse venous sinus, a vein in the brain. The stenting is performed by a neuro-radiological intervention. Follow-up visits are scheduled at 1, 3, and 12 months after treatment to monitor progress. During the study, patients will undergo eye exams and imaging tests to assess symptoms like papilledema (swelling of the optic nerve), headaches, and visual function. Researchers will measure how many patients have resolved papilledema and normalized intracranial pressure after 3 months, along with additional assessments of headache severity, tinnitus, vision, autonomy, and cognition over 12 months. Safety and adherence to treatments will be monitored throughout the trial, which is sponsored by the University Hospital, Montpellier.
CONDITIONS
Brief Title
Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at inclusion
- New diagnosis of idiopathic intracranial hypertension within the last 3 months meeting modified Dandy criteria
- Intracranial transverse venous sinus stenosis on dominant sinus with hypoplastic contralateral sinus or bilateral stenosis confirmed by MRI
- Normal MRI except for venous sinus stenosis or IIH-related abnormalities
- Ophthalmologic symptoms and signs related to IIH including retinal nerve fiber layer thickness ≥130 µm and Frisen score ≥2
- No macular ganglion cell atrophy on optical coherence tomography
- Signed informed consent
- Ability to attend all scheduled visits and comply with study procedures
- Coverage by public health insurance
You will not qualify if you...
- Prior treatment with acetazolamide for IIH
- Allergy to contrast products, nickel, or titanium
- Recent exposure (within 2 months) to drugs associated with increased intracranial pressure such as lithium, vitamin A, or tetracycline
- History of intracranial venous thrombosis or brain tumors
- Rapid vision loss defined as decrease of 3/10 or more in 4 weeks without other eye disease
- Macular ganglion cell atrophy on OCT
- Optic nerve atrophy
- Amblyopia
- Significant refractive errors with eye abnormalities or previous glaucoma
- Positive pregnancy test if applicable
- Severe or fatal comorbidities affecting follow-up or procedure benefit
- Evidence of intracranial hemorrhage
- Life expectancy under 6 months
- Chronic IIH
- Renal failure with creatinine >1.5 mg/dl or clearance <60 mL/min unless on dialysis
- Previous intracranial sinus stent implantation
- Previous gastric bypass surgery
- Contraindications to general anesthesia or certain anti-platelet drugs
- History of severe respiratory disease, deep vein thrombosis, pulmonary embolism, or atrial fibrillation
- Cerebral vascular lesions affecting safe stenting
- Venous sinus anatomy preventing safe catheterization
- Employment or dependency related to sponsor or investigator
- Participation in another clinical trial or use of unapproved drugs within 4 weeks
- Legal protections such as pregnancy, guardianship, or incarceration
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 - Up to 3 months
Participants receive either transverse venous sinus stenting or best medical care including acetazolamide and recommended weight loss as first-line treatment for idiopathic intracranial hypertension.
Visits at baseline, and periodic follow-up visits up to 3 months
Duration - Up to 12 months
Participants are monitored for symptom improvement and safety after treatment, including headache frequency, visual function, and cognition.
Follow-up visits at 3 and 12 months
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
A
Anne DUCROS, 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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