Idiopathic Intracranial Hypertension (IIH)VEHICLENCT06692790
VEHICLE Registry: Venous Stenting for IIH in the MENA Region
An observational study of Idiopathic Intracranial Hypertension (IIH), run by Middle East North Africa Stroke and Interventional Neurotherapies Organization at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH)
- What is being tested?
- Venous Sinus Stenting Procedure
- How many people
- 150 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Aug 2021to 11 Nov 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients diagnosed with Idiopathic Intracranial Hypertension who are candidates for venous sinus stenting, recruited from multiple centers across the MENA region.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University
Alexandria
ossama yassin mansour, MD, PhD, +201223926932, ossama.mansour@alexmed.edu.eg
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdullah Medical City (KAMC) -
Mecca
About this study
Official title: 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.
Read the 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.
- Being tested
- Venous Sinus Stenting Procedure
- Keywords
- Venous Sinus Stenosis, Venous Sinus Stenting, Papilledema, Middle East and North Africa (MENA), Magnetic Resonance Venography (MRV)
- Medical subject headings
- Pseudotumor Cerebri, Papilledema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous Sinus Stenting ProcedureOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Improvement
Proportion of patients reporting significant improvement or resolution of IIH symptoms (headache, visual disturbances, tinnitus) at six months post-venous sinus stenting.
Measured: 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.
Measured: 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.
Measured: Baseline and six months post-procedure.
Secondary outcomes (4)
Stent Patency Rate
Proportion of patients with patent venous sinus stents as assessed by imaging (MRV or DSA) at six months follow-up.
Measured: Six months post-procedure.
Adverse Events
Incidence of procedural complications or adverse events related to venous sinus stenting within six months post-procedure.
Measured: Up to six months post-procedure.
Visual Field Improvement
Improvement in visual field defects assessed by perimetry testing at six months post-procedure.
Measured: Six months post-procedure.
Cranial Neuropathy Resolution
Resolution or improvement of cranial neuropathies (e.g., sixth nerve palsy) at six months post-procedure.
Measured: Six months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start11 Aug 2021
- Primary completion11 Aug 2025 (estimated)
- Study completion11 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ossama Mansour, Middle East North Africa Stroke and Interventional Neurotherapies Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692790
- Sponsor's protocol ID
- MENASINO1001S
- Acronym
- VEHICLE
- Status last verified
- May 2024
- First submitted
- 15 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous StEnt for Idiopathic IntraCranial HypertEnsion (VEHICLE) Registry: Management and Outcomes in the MENA Region
- ClinicalTrials.gov ID
- NCT06692790
- Acronym / sponsor ID
- VEHICLE / MENASINO1001S
- Keywords
- Venous Sinus Stenosis, Venous Sinus Stenting, Papilledema, Middle East and North Africa (MENA), Magnetic Resonance Venography (MRV)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies OrganizationUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 11 Aug 2025 (estimated)
- Study completion
- 11 Nov 2025 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients diagnosed with Idiopathic Intracranial Hypertension who are candidates for venous sinus stenting, recruited from multiple centers across the MENA region.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous Sinus Stenting ProcedurePerformed 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 | Other | – |
Primary outcome
Symptom Improvement
Time frame: Six months post-procedure.
Proportion of patients reporting significant improvement or resolution of IIH symptoms (headache, visual disturbances, tinnitus) at six months post-venous sinus stenting.
Change in Papilledema Grade
Time frame: Six months post-procedure.
Improvement in papilledema grade assessed by fundoscopic examination using the Frisén scale from baseline to six months post-procedure.
Quality of Life Improvement
Time frame: Baseline and six months post-procedure.
Change in Quality of Life (QOL) scores measured using a standardized questionnaire from baseline to six months post-procedure.
4 secondary outcomes
Stent Patency Rate
Time frame: Six months post-procedure.
Adverse Events
Time frame: Up to six months post-procedure.
Visual Field Improvement
Time frame: Six months post-procedure.
Cranial Neuropathy Resolution
Time frame: Six months post-procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Intracranial Hypertension (IIH), run by Middle East North Africa Stroke and Interventional Neurotherapies Organization at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ossama yasssin mansour, MD, PhD (+19297216189, ossama.mansour@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Improvement (time frame: Six months post-procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.