NCT06692790

VEHICLE Registry: Venous Stenting for IIH in the MENA Region

Venous StEnt for Idiopathic IntraCranial HypertEnsion (VEHICLE) Registry: Management and Outcomes in the MENA Region

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Idiopathic Intracranial Hypertension (IIH)

Interventions

Type	Name	Description
OTHER	Venous Sinus Stenting Procedure	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

Timeline

• Start date: 2021-08-11
• Primary completion: 2025-08-11
• Completion: 2025-11-11
• First posted: 2024-11-18
• Last updated: 2024-11-18

Locations

2 sites across 2 countries: Egypt, Saudi Arabia