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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous Sinus Stenting Procedure | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Improvement | Proportion of patients reporting significant improvement or resolution of IIH symptoms (headache, visual disturbances, tinnitus) at six months post-venous sinus stenting. | 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. | 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. | Baseline and six months post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Patency Rate | Proportion of patients with patent venous sinus stents as assessed by imaging (MRV or DSA) at six months follow-up. | Six months post-procedure. |
| Adverse Events | Incidence of procedural complications or adverse events related to venous sinus stenting within six months post-procedure. |
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Inclusion Criteria:
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 Hâ‚‚O) 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:
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.
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Patients diagnosed with Idiopathic Intracranial Hypertension who are candidates for venous sinus stenting, recruited from multiple centers across the MENA region.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ossama yasssin mansour, MD, PhD | Contact | +19297216189 | ossama.mansour@alexmed.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Recruiting | Alexandria | Egypt |
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.
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.
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.
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| D010211 | Papilledema |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Up to six months post-procedure. |
| Visual Field Improvement | Improvement in visual field defects assessed by perimetry testing at six months post-procedure. | Six months post-procedure. |
| Cranial Neuropathy Resolution | Resolution or improvement of cranial neuropathies (e.g., sixth nerve palsy) at six months post-procedure. | Six months post-procedure. |
| King Abdullah Medical City (KAMC) - | Recruiting | Mecca | Saudi Arabia |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |