VEHICLE Registry: Venous Stenting for IIH in the MENA Region (VEHICLE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Intracranial Hypertension (IIH)
• Intervention / Treatment: Other: Venous Sinus Stenting Procedure

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: ossama yasssin mansour, MD, PhD; Phone Number: +19297216189; Email: ossama.mansour@alexmed.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University
    • Contact: ossama yassin mansour, MD, PhD; Phone Number: +201223926932; Email: ossama.mansour@alexmed.edu.eg
• Saudi Arabia
  • Makkah, Saudi Arabia
    • Recruiting
    • King Abdullah Medical City (KAMC) -

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Idiopathic Intracranial Hypertension who are candidates for venous sinus stenting, recruited from multiple centers across the MENA region.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Estimated): August 11, 2025
• Study Completion (Estimated): November 11, 2025

Study Registration Dates

• First Submitted: November 15, 2024
• First Submitted That Met QC Criteria: November 15, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Papilledema; Venous Sinus Stenting; Venous Sinus Stenosis; Middle East and North Africa (MENA); Magnetic Resonance Venography (MRV)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hypertension; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: MENASINO1001S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No