Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06945848

Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide

Led by University Hospital, Montpellier · Updated on 2026-03-06

114

Participants Needed

3

Research Sites

208 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

This study is aimed at patients suffering from long term intracranial hypertension (caracterized by visual loss, chronic headache and/or tinnitus), receiving acetazolamide for more than 1 year, having inadequate response to treatment (untolerable side effects or insufficient efficacy). 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 care + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.

CONDITIONS

Official Title

Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 best medical management including acetazolamide for more than 1 year
  • Elevated intracranial pressure greater than 25 cm H2O or 18 mmHg
  • Intracranial transverse venous sinus stenosis on dominant sinus with hypoplastic contralateral sinus or bilateral stenosis confirmed by MRI
  • Normal MRI findings except for transverse venous sinus stenosis or IIH-related abnormalities
  • Provided signed and dated informed consent
  • Able to attend all scheduled visits and comply with study procedures
  • Covered by public health insurance
Not Eligible

You will not qualify if you...

  • Use of topiramate within the previous month
  • Known allergy to contrast products, nickel, or titanium
  • Exposure within 2 months to drugs or substances known to elevate intracranial pressure (e.g., lithium, vitamin A, tetracycline)
  • History of intracranial venous thrombosis or intracranial tumors
  • Rapid vision loss due to IIH defined as loss of at least 3/10 in the worse eye within 4 weeks without other eye disease
  • Optic nerve atrophy
  • Amblyopia
  • Significant refractive error with fundus abnormalities or other eye disorders causing vision loss
  • Pregnancy or positive pregnancy test in women 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
  • Prior gastric bypass surgery
  • Contraindication to general anesthesia
  • Contraindication to aspirin, clopidogrel, or other P2Y12 anti-aggregants
  • History of severe respiratory disease such as COPD
  • History of deep vein thrombosis or pulmonary embolism
  • History of atrial fibrillation or stroke risk factors
  • Cerebral vascular lesions or anomalies preventing safe stenting
  • Employment or dependency relation with study sponsor or investigator
  • Participation in another clinical trial or unapproved drug use within 4 weeks before screening
  • Under legal protection such as prisoners, patients under guardianship, or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

Research Team

V

Vincent COSTALAT, 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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here