VEHICLE Registry: Venous Stenting for IIH in the MENA Region

NCT ID: NCT06692790

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-11
• Study Completion Date: 2025-11-11

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.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Middle East North Africa Stroke and Interventional Neurotherapies Organization

OTHER

Sponsor Role: lead

Responsible Party

Ossama Mansour

Professor of Neurology and stroke

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alexandria University

Alexandria, , Egypt

Site Status: RECRUITING

King Abdullah Medical City (KAMC) -

Mecca, , Saudi Arabia

Site Status: RECRUITING

Countries

Egypt; Saudi Arabia

Central Contacts

ossama yasssin mansour, MD, PhD

Role: CONTACT

ossama.mansour@alexmed.edu.eg

+19297216189

Facility Contacts

ossama yassin mansour, MD, PhD

Role: primary

ossama.mansour@alexmed.edu.eg

+201223926932

Other Identifiers

MENASINO1001S

Identifier Type: -

Identifier Source: org_study_id