Clinical trial NCT06692790: VEHICLE Registry: Venous Stenting for IIH in the MENA Region
Official title: Venous StEnt for Idiopathic IntraCranial HypertEnsion (VEHICLE) Registry: Management and Outcomes in the MENA Region
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Idiopathic Intracranial Hypertension (IIH)
Keywords: Venous Sinus Stenosis
Venous Sinus Stenting
Papilledema
Middle East and North Africa (MENA)
Magnetic Resonance Venography (MRV)
Lead sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Symptom Improvement
timeFrame: Six months post-procedure.
measure: Change in Papilledema Grade
timeFrame: Six months post-procedure.
measure: Quality of Life Improvement
timeFrame: Baseline and six months post-procedure.
Secondary outcomes:
measure: Stent Patency Rate
timeFrame: Six months post-procedure.
measure: Adverse Events
timeFrame: Up to six months post-procedure.
measure: Visual Field Improvement
timeFrame: Six months post-procedure.
measure: Cranial Neuropathy Resolution
timeFrame: Six months post-procedure.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
city: Makkah
country: Saudi Arabia
facility: King Abdullah Medical City (KAMC) -
Study officials:
References: