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.
Study Type
OBSERVATIONAL
Enrollment
150
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
Alexandria University
Alexandria, Egypt
RECRUITINGKing Abdullah Medical City (KAMC) -
Mecca, Saudi Arabia
RECRUITINGSymptom 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.
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