Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT06059703
Eligibility Criteria:
Inclusion Criteria:
* 18 years and older
* Patients with newly diagnosed untreated HII (following the modified Dandy criteria) with normal CSF composition, abnormal CSF pressure at the lumbar puncture (\>25 cm H2O), and significant pressure gradient at the level of the stenosis (≥8 mmHg)
* Presence of bilateral transverse sinus stenosis (or unilateral with hypoplastic contralateral sinus).
Exclusion Criteria:
* Allergy to contrast media (nickel, titanium)
* Allergy or contraindication to antiplatelet agents
* Patient on anti-inflammatory treatment
* Chronic inflammatory disease
* History of intracranial venous thrombosis, cerebral hemorrhage, thrombophilia
* History of intracranial tumor
* Fulminant IIH with acute visual loss
* Optic nerve atrophy with papilledema (chronic IIH)
* Female being pregnant, breastfeeding, or planning to become pregnant in the next 3 months
* Major comorbidities with high procedural risk
* Life expectancy \< 6 months
* Adult under guardianship or conservatorship or incapacitated
* Refusal of consent after receiving all necessary information
* Not covered by or not a beneficiary of the French social security system
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06059703
Study Brief:
Protocol Section:
NCT06059703