VEHICLE Registry: Venous Stenting for IIH in the MENA Region

Recruiting

• Conditions: Idiopathic Intracranial Hypertension (IIH)

• Registration Number: NCT06692790
• Lead Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization

Brief 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.

Study Timeline

• Study Start: 2021-08-11
• Status Verified: 2024-05
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18
• Primary Completion: 2025-08-11
• Study Completion: 2025-11-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom Improvement	Six months post-procedure.	Proportion of patients reporting significant improvement or resolution of IIH symptoms (headache, visual disturbances, tinnitus) at six months post-venous sinus stenting.
Change in Papilledema Grade	Six months post-procedure.	Improvement in papilledema grade assessed by fundoscopic examination using the Frisén scale from baseline to six months post-procedure.
Quality of Life Improvement	Baseline and six months post-procedure.	Change in Quality of Life (QOL) scores measured using a standardized questionnaire from baseline to six months post-procedure.

Secondary Outcome Measures

Name	Time	Method
Stent Patency Rate	Six months post-procedure.	Proportion of patients with patent venous sinus stents as assessed by imaging (MRV or DSA) at six months follow-up.
Adverse Events	Up to six months post-procedure.	Incidence of procedural complications or adverse events related to venous sinus stenting within six months post-procedure.
Cranial Neuropathy Resolution	Six months post-procedure.	Resolution or improvement of cranial neuropathies (e.g., sixth nerve palsy) at six months post-procedure.
Visual Field Improvement	Six months post-procedure.	Improvement in visual field defects assessed by perimetry testing at six months post-procedure.

Trial Locations

Locations (2)

Alexandria University; 🇪🇬 Alexandria, Egypt

King Abdullah Medical City (KAMC) -; 🇸🇦 Makkah, Saudi Arabia