Actively Recruiting
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
188 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
This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.
CONDITIONS
Official 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...
- Participant is 18 years old or older at the time of inclusion
- New diagnosis of idiopathic intracranial hypertension within 3 months meeting modified Dandy criteria
- Presence of intracranial transverse venous sinus stenosis on dominant side with hypoplastic opposite side, or bilateral stenosis confirmed by MRI
- Normal MRI except findings related to transverse venous sinus stenosis or IIH
- Presence of ophthalmologic symptoms and signs of IIH (e.g., retinal nerve fiber layer thickness ≥ 130 µm, Frisen score ≥ 2)
- No macular ganglion cell atrophy observed on optical coherence tomography (OCT)
- Signed informed consent form after receiving study information
- Ability to attend all scheduled visits and comply with study procedures
- Covered by public health insurance
You will not qualify if you...
- Previous treatment with acetazolamide for IIH
- Known allergy to contrast products, nickel, or titanium
- Use of oral drugs or substances linked to increased intracranial pressure within 2 months prior to diagnosis (e.g., lithium, vitamin A, tetracycline)
- History of intracranial venous thrombosis or brain tumors
- Severe recent vision loss defined as at least 3/10 decrease in corrected vision over 4 weeks without other eye diseases
- Macular ganglion cell atrophy on OCT
- Optic nerve atrophy
- Amblyopia
- Significant refractive errors combined with abnormal eye findings or previous glaucoma
- Positive pregnancy test in women of childbearing potential
- Severe or fatal comorbidities limiting improvement or follow-up
- Evidence of intracranial hemorrhage
- Life expectancy under 6 months
- Chronic IIH
- Renal failure (creatinine > 1.5 mg/dl or clearance < 60 mL/min unless on hemodialysis)
- Prior intracranial sinus stent implantation
- Previous gastric bypass surgery
- Contraindications to general anesthesia or specific blood thinners (aspirin, clopidogrel, P2Y12 inhibitors)
- History of severe respiratory diseases, deep vein thrombosis, pulmonary embolism, atrial fibrillation, or stroke risk
- Cerebral vascular abnormalities preventing safe stenting
- Anatomical vein anomalies preventing catheterization and stenting
- Employment or dependency relationship with the sponsor or investigator
- Participation in another clinical trial or use of unapproved drugs within 4 weeks prior to screening
- Legal protections such as pregnancy, guardianship, or incarceration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
F
Fédérico CAGNAZZO, MD, PhD
CONTACT
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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