VEHICLE Registry: Venous Stenting for IIH in the MENA Region

NCT06692790 | Recruiting DMC

• 1 other identifier: MENASINO1001S
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 2

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.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Keywords

Venous Sinus Stenosis; Venous Sinus Stenting; Papilledema; Middle East and North Africa (MENA); Magnetic Resonance Venography (MRV)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Stent Patency Rate

  Six months post-procedure.

• Adverse Events

  Up to six months post-procedure.

• Visual Field Improvement

  Six months post-procedure.

• Cranial Neuropathy Resolution

  Six months post-procedure.

Interventions

Venous Sinus Stenting Procedure OTHER

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Alexandria University

Alexandria, Egypt

RECRUITING

King Abdullah Medical City (KAMC) -

Mecca, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Pseudotumor Cerebri; Papilledema

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Central Study Contacts

ossama yasssin mansour, MD, PhD

CONTACT

+19297216189; ossama.mansour@alexmed.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology and stroke

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: August 11, 2021
• Primary Completion: August 11, 2025
• Study Completion: November 11, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

SA (1); EG (1)