RecruitingNCT06692790

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

Sponsor

Middle East North Africa Stroke and Interventional Neurotherapies Organization

Enrollment

150 participants

Start Date

Aug 11, 2021

Study Type

OBSERVATIONAL

Conditions

Idiopathic Intracranial Hypertension (IIH)

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria8

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 Criteria2

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.

Interventions

OTHERVenous 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