Registry for venous stenting in patients with IIH in the MENA region
Venous StEnt for Idiopathic IntraCranial HypertEnsion (VEHICLE) Registry: Management and Outcomes in the MENA Region
This study is trying to see how well venous sinus stenting works for people with Idiopathic Intracranial Hypertension in the Middle East and North Africa who haven't found relief from other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Middle East North Africa Stroke and Interventional Neurotherapies Organization Academic / other |
| Locations | 2 sites (Alexandria and 1 other locations) |
| Trial ID | NCT06692790 on ClinicalTrials.gov |
What this trial studies
The VEHICLE Registry is a multicenter observational initiative that evaluates the management and outcomes of patients with Idiopathic Intracranial Hypertension (IIH) undergoing venous sinus stenting in the Middle East and North Africa (MENA) region. This study collects real-world data to assess clinical characteristics, treatment efficacy, safety, and the role of venous sinus stenting as a therapeutic option for patients who are refractory to medical therapy. Participants will be followed for six months to analyze demographics, clinical presentations, imaging findings, treatment details, and outcomes. The goal is to enhance understanding and management of IIH in this specific population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 diagnosed with IIH who are refractory to medical therapy or intolerant to medications.
Not a fit: Patients with secondary causes of intracranial hypertension or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of venous sinus stenting as a treatment for IIH, potentially improving patient outcomes.
How similar studies have performed: While venous sinus stenting has shown promise in treating IIH, this registry aims to gather real-world data, making it a novel approach in the MENA region.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 60 years. Diagnosed with Idiopathic Intracranial Hypertension (IIH) based on the modified Dandy criteria, including: Symptoms of increased intracranial pressure (e.g., headache, visual disturbances). Elevated opening pressure (\>250 mm H₂O) on lumbar puncture with normal cerebrospinal fluid composition. No evidence of intracranial pathology (e.g., mass lesion, hydrocephalus) on neuroimaging. Presence of papilledema. Evidence of venous sinus stenosis on Magnetic Resonance Venography (MRV) or Digital Subtraction Angiography (DSA). Refractory to medical therapy or intolerant to medications (e.g., acetazolamide). Willingness to undergo venous sinus stenting. Provided informed consent for participation. Exclusion Criteria: * Secondary causes of intracranial hypertension (e.g., cerebral venous sinus thrombosis, neoplasm). Coagulopathies or contraindications to antiplatelet or anticoagulation therapy. Pregnancy or lactation. Incomplete baseline data or inability to complete follow-up assessments. Severe comorbid conditions that preclude endovascular procedures.
Where this trial is running
Alexandria and 1 other locations
- Alexandria University — Alexandria, Egypt (Recruiting)
- King Abdullah Medical City (KAMC) - — Mecca, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: ossama yasssin mansour, MD, PhD
- Email: ossama.mansour@alexmed.edu.eg
- Phone: +19297216189
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.