An observational study in Idiopathic Intracranial Hypertension (IIH), sponsored by Middle East North Africa Stroke and Interventional Neurotherapies Organization. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Middle East North Africa Stroke and Interventional Neurotherapies Organization · Observational
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.
Idiopathic Intracranial Hypertension (IIH) is a condition characterized by elevated intracranial pressure without an identifiable cause, leading to symptoms such as headaches, visual disturbances, and potential vision loss due to papilledema. The condition predominantly affects obese women of childbearing age and is associated with risk factors like obesity, recent weight gain, hypothyroidism, and polycystic ovary syndrome (PCOS).
Venous sinus stenosis has been implicated in the pathophysiology of IIH. Venous sinus stenting has emerged as a promising treatment option for patients who are refractory to medical therapy or intolerant to medications like acetazolamide.
The VEHICLE Registry collects real-world data from multiple centers in the MENA region to evaluate the efficacy and safety of venous sinus stenting in patients with IIH. The registry analyzes patient demographics, clinical presentations, imaging findings, treatment details, and outcomes over a six-month follow-up period to improve understanding and management of IIH in this population.
53 studies on the registry are indexed under Pseudotumor Cerebri; 22 are open to participants now.
This study's planned enrollment of 150 is above the median of 64 across 17 observational studies indexed under Pseudotumor Cerebri.
Browse Pseudotumor Cerebri studies →Middle East North Africa Stroke and Interventional Neurotherapies Organization is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with Idiopathic Intracranial Hypertension who are candidates for venous sinus stenting, recruited from multiple centers across the MENA region.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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).
to medical therapy or intolerant to medications (e.g., acetazolamide).
Willingness to undergo venous sinus stenting. Provided for participation.
Exclusion Criteria:
Coagulopathies or 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Performed under general or local anesthesia. Targeted stenosis sites included the right transverse sinus, left transverse sinus, bilateral transverse sinuses, and right transverse and sigmoid sinuses. Stents used included Venous Sinus Stent (CWS), CASPER, PRTCS, and multiple stents where necessary. Post-procedure care included antiplatelet therapy and routine follow-up assessments
Symptom Improvement
Proportion of patients reporting significant improvement or resolution of IIH symptoms (headache, visual disturbances, tinnitus) at six months post-venous sinus stenting.
Time frame: Six months post-procedure.
Change in Papilledema Grade
Improvement in papilledema grade assessed by fundoscopic examination using the Frisén scale from baseline to six months post-procedure.
Time frame: Six months post-procedure.
Quality of Life Improvement
Change in Quality of Life (QOL) scores measured using a standardized questionnaire from baseline to six months post-procedure.
Time frame: Baseline and six months post-procedure.
Stent Patency Rate
Proportion of patients with patent venous sinus stents as assessed by imaging (MRV or DSA) at six months follow-up.
Time frame: Six months post-procedure.
Adverse Events
Incidence of procedural complications or adverse events related to venous sinus stenting within six months post-procedure.
Time frame: Up to six months post-procedure.
Visual Field Improvement
Improvement in visual field defects assessed by perimetry testing at six months post-procedure.
Time frame: Six months post-procedure.
Cranial Neuropathy Resolution
Resolution or improvement of cranial neuropathies (e.g., sixth nerve palsy) at six months post-procedure.
Time frame: Six months post-procedure.
Plan to share: Yes — The VEHICLE Registry plans to share de-identified individual participant data (IPD) to promote transparency and facilitate further research in the field of Idiopathic Intracranial Hypertension (IIH). Sharing this data aims to contribute to a better understanding of IIH management and outcomes, especially regarding venous sinus stenting in the Middle East and North Africa (MENA) region.
Supporting information: Study protocol
Time frame: Data will be available beginning 6 months after publication of the primary study results. Data availability will continue for a period of 5 years following the initial publication.
Access criteria: Qualified researchers affiliated with academic institutions, research organizations, or medical institutions. Researchers who provide a methodologically sound research proposal that is approved by an independent review committee.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Middle East North Africa Stroke and Interventional Neurotherapies Organization