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New treatment option for Idiopathic Intracranial Hypertension (IIH)
Official title Intracranial Venous Stenting Evaluation in Patients With Idiopathic Intracranial Hypertension in the Early Phase
ClinicalTrials.gov ID: NCT06919744
What this study is testing
What is Best medical care?
Best medical care is an investigational medicine, being studied as a potential treatment for idiopathic intracranial hypertension (iih).
Also referred to as Acetazolamide, Weight loss.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject is ≥ 18 years old at inclusion.
- Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
- Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
- Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
- Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)
You likely can't join if
- Subject previously treated with acetazolamide for IIH
- Known contrast product, Nickel, titanium allergy
- Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis...
- History of intracranial venous thrombosis or intracranial neoplasia
- 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...
- Macular ganglion cells atrophy seen on OCT
See the full eligibility criteria
- Subject is ≥ 18 years old at inclusion.
- Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
- Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
- Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
- Subject with ophthalmologic IIH symptoms and signs (RNFL ≥ 130 µm, Frisen score ≥ 2, and absence of differential diagnostic)
- Subject without macular ganglion cells atrophy seen on OCT
- Patient having received information about data collection and having signed and dated an Informed Consent Form
- people must be able to attend all scheduled visits and to comply with all trial procedures
- people must be covered by public health insurance
- Subject previously treated with acetazolamide for IIH
- Known contrast product, Nickel, titanium allergy
- Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)
- History of intracranial venous thrombosis or intracranial neoplasia
- 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...
- Macular ganglion cells atrophy seen on OCT
- Optic nerve atrophy
- Amblyopia
- 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
- Pregnancy: if a woman is of childbearing potential a urine or serum beta HCG test is positive
- 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.
- Evidence of intracranial hemorrhage (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH), etc.)
- Life expectancy under 6 months
- Chronic IIH
- Patients with renal failure (creatinine \> 1.5 mg/dl and/or creatinine clearance \< 60 mL/min, except if patient is already on hemodialysis)
- History of previously implanted intra-cranial sinus stent
- Previous gastric bypass surgery
- Contra-indication to general anesthesia
- Contra-indication to aspirin, clopidogrel or other P2Y12 anti-aggregant
- History of chronic obstructive pulmonary disease or other severe respiratory disease
- History of deep vein thrombosis or pulmonary embolism
- History of atrial fibrillation or other risks of stroke
- 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...
- Anatomical anomaly of the venous sinus which would prevent safe catheterization and stenting
- Subject who are in a dependency or employment with the sponsor or the investigator
- Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
- Reims, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France; Reims, France; Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.