VEHICLE Registry: Venous Stenting for IIH in the MENA Region (NCT06692790) | Clinical Trial Compass
UnknownNot Applicable
VEHICLE Registry: Venous Stenting for IIH in the MENA Region
Egypt, Saudi Arabia150 participantsStarted 2021-08-11
Plain-language summary
The VEHICLE Registry is a multicenter observational study aimed at evaluating the management and outcomes of patients with Idiopathic Intracranial Hypertension (IIH) undergoing venous sinus stenting in the Middle East and North Africa (MENA) region. The study focuses on assessing clinical characteristics, treatment efficacy, safety, and the role of venous sinus stenting as a therapeutic modality in IIH.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptom Improvement
Timeframe: Six months post-procedure.
2
Change in Papilledema Grade
Timeframe: Six months post-procedure.
3
Quality of Life Improvement
Timeframe: Baseline and six months post-procedure.
Trial details
NCT IDNCT06692790
SponsorMiddle East North Africa Stroke and Interventional Neurotherapies Organization