Idiopathic Intracranial Hypertension (IIH)NCT06833424
Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension
A study testing Dural venous sinus stenting in people with Idiopathic Intracranial Hypertension (IIH), run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH)
- What is being tested?
- Dural venous sinus stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 40 Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH).
- Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema.
- No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis.
- Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities.
- No etiology for increased intracranial pressure: On neuroimaging findings.
- Age: 18-60 years
- Gender: Male or Female Inclusion Criteria.
Who cannot join
- Age less than or equal to 18 years.
- severe allergic reaction to iodine contrast or chronic Kidney disease.
- contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis
- patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine
Asyut, 2063045
Mohamed Zayed Zayed, mzayeds1206@gmai.com
About this study
Official title: Predictors of Dural Venous Sinus Stenting in Idiopathic Intracranial Hypertension Patients and Outcomes
This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.
Read the detailed description
Idiopathic intracranial hypertension (IIH) has long been associated with the hallmark clinical triad of headaches, papilledema, and visual loss in the absence of neurologic signs (except possible CN VI palsy), Hydrocephalus or intracranial masses on CT or MRI. findings without evidence of thrombosis; lumbar puncture opening pressure of >25 cmH2O; normal biochemical and cytological composition of the CSF. The overall age-adjusted and gender-adjusted annual incidence is increasing and was reported to be 2.4 per 100 000 within the last decade (2002-2014).A variety of aetiologies have been suggested to explain the pathophysiology behind IIH, including meningeal inflammation, metabolic disturbances (e.g., hyper- or hypoadrenalism and hypoparathyroidism), medication effects (e.g., excess vitamin A, corticosteroids, and tetracycline), and cerebral venous hypertension.Imaging of patients with IIH is traditionally performed to exclude lesions that produce intracranial hypertension. MR imaging features of IIH include posterior globe flattening, a protrusion of the subarachnoid space in the cavum sellae (Empty Sella), distension of the preoptic subarachnoid space, enhancement of the prelaminar optic nerve, vertical tortuosity of the orbital optic nerve, and intraocular protrusion of the prelaminar optic nerve. Although these findings support the presence of elevated ICP and, thus, the diagnosis of IIH, they are not predictive of the severity of visual loss, and their absence does not exclude the diagnosis. It should not guide a specific management of patients with IIH .
The first line of treatment for IIH consists of weight loss and/or medical therapy including diuretics such as acetazolamide. When medical treatment fails, surgical options include cerebrospinal fluid (CSF) diversion via ventriculoperitoneal (VP) or lumboperitoneal (LP) shunting or optic nerve sheath fenestration. Recently, another etiology of cerebral venous hypertension has garnered increasing attention as a putative cause of IIH, cerebral venous Dural sinus stenosis. In medically refractory IIH patients with a physiologic pressure gradient across venous stenosis, cerebral venous stenting has emerged as an alternative treatment to traditional surgical approaches.
Transverse sinus stenosis can be seen in 2 morphologic forms: an extrinsic smooth gradually narrowing tapered stenosis and intrinsic discrete obstructions, presumably due to arachnoid granulations or fibrous septae. While intrinsic transverse sinus stenosis might cause IIH by completely occluding the transverse sinus, the extrinsic compression resolves with CSF drainage. might be secondary to intracranial hypertension. Venous sinus stenting (VSS) reduces intracranial venous pressures and improves idiopathic intracranial hypertension (IIH) symptoms.
- Being tested
- Dural venous sinus stenting
- Keywords
- predictors and outcomes
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural venous sinus stentingProcedure or surgery
40 patients with idiopathic intracranial hypertension according to Modified Dandy Criteria will subjected to Dural venous stenting
| Study group | Role | What they receive |
|---|---|---|
| Dural Venous sinus stent | Experimental | 40 Patients Diagnosed with idiopathic intracranial hypertension according to modified Dandy Criteria subjected to Dural venous sinus stenting Receives: Procedure: Dural venous sinus stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in headache impact scale(HIT-6)
The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function. minimum score 36 and maximum score 78
Measured: 3, 6 months
Papilledema Friesen grading scale
The Frisen grading system is an objective criteria used to describe the degree of papilledema, which is swelling of the optic disc from increased ICP grading from zero to 5
Measured: 3 months and 6 months
Visual filed Assessment Perimetry
Perimetry is the systematic measurement of visual field function (the total area where objects can be seen in the peripheral vision while the eye is focused on a central point).
Measured: 3,6 months
Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration
changes in other symptomology including tinnitus ,abducent nerve palsyand TVO
Measured: 3,6 months
Secondary outcomes (4)
Stent Patency and pressure change
Diagnostic DSA follow up and measuring pressure gradient changes pre and post stenting
Measured: 6 months
stent Patency
in stent stenosis and Adjacent stent stenosis
Measured: 6 months
Safety outcome measures
Safety outcomes of occurrences of complication: Subdural Hematoma, Subarachnoid Hemorrhage, Intracerebral hematoma puncture site complication (retroperitoneal hematoma or femoral artery aneurysm)
Measured: 10 days
Quality of life improvement
Quality of life measure: SF-36 for fatigue.
Measured: 3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zayed Saber, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833424
- Sponsor's protocol ID
- intracranial hypertension
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hilvert AM, Gauhar F, Longo M, Grimaudo H, Dugan J, Mummareddy N, Chitale R, Froehler MT, Fusco MR. Venous sinus stenting versus ventriculoperitoneal shunting: comparing clinical outcomes for idiopathic intracranial hypertension. J Neurointerv Surg. 2024 Nov 22;16(12):1264-1267. doi: 10.1136/jnis-2024-022174.
PubMed 39209429McGonigal A, Bone I, Teasdale E. Resolution of transverse sinus stenosis in idiopathic intracranial hypertension after L-P shunt. Neurology. 2004 Feb 10;62(3):514-5. doi: 10.1212/wnl.62.3.514. No abstract available.
PubMed 14872049Subramaniam RM, Tress BM, King JO, Eizenberg N, Mitchell PJ. Transverse sinus septum: a new aetiology of idiopathic intracranial hypertension? Australas Radiol. 2004 Jun;48(2):114-6. doi: 10.1111/j.1440-1673.2004.01269.x.
PubMed 15230741Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2.
PubMed 28255904Saindane AM, Bruce BB, Riggeal BD, Newman NJ, Biousse V. Association of MRI findings and visual outcome in idiopathic intracranial hypertension. AJR Am J Roentgenol. 2013 Aug;201(2):412-8. doi: 10.2214/AJR.12.9638.
PubMed 23883223Degnan AJ, Levy LM. Pseudotumor cerebri: brief review of clinical syndrome and imaging findings. AJNR Am J Neuroradiol. 2011 Dec;32(11):1986-93. doi: 10.3174/ajnr.A2404. Epub 2011 Jun 16.
PubMed 21680652Brodsky MC, Vaphiades M. Magnetic resonance imaging in pseudotumor cerebri. Ophthalmology. 1998 Sep;105(9):1686-93. doi: 10.1016/S0161-6420(98)99039-X.
PubMed 9754178Kilgore KP, Lee MS, Leavitt JA, Mokri B, Hodge DO, Frank RD, Chen JJ. Re-evaluating the Incidence of Idiopathic Intracranial Hypertension in an Era of Increasing Obesity. Ophthalmology. 2017 May;124(5):697-700. doi: 10.1016/j.ophtha.2017.01.006. Epub 2017 Feb 7.
PubMed 28187976Starke RM, Wang T, Ding D, Durst CR, Crowley RW, Chalouhi N, Hasan DM, Dumont AS, Jabbour P, Liu KC. Endovascular Treatment of Venous Sinus Stenosis in Idiopathic Intracranial Hypertension: Complications, Neurological Outcomes, and Radiographic Results. ScientificWorldJournal. 2015;2015:140408. doi: 10.1155/2015/140408. Epub 2015 Jun 4.
PubMed 26146651Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b.
PubMed 12455560Radhakrishnan K, Ahlskog JE, Garrity JA, Kurland LT. Idiopathic intracranial hypertension. Mayo Clin Proc. 1994 Feb;69(2):169-80. doi: 10.1016/s0025-6196(12)61045-3.
PubMed 8309269
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Dural Venous Sinus Stenting in Idiopathic Intracranial Hypertension Patients and Outcomes
- ClinicalTrials.gov ID
- NCT06833424
- Acronym / sponsor ID
- intracranial hypertension
- Keywords
- predictors and outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.
Detailed description
Idiopathic intracranial hypertension (IIH) has long been associated with the hallmark clinical triad of headaches, papilledema, and visual loss in the absence of neurologic signs (except possible CN VI palsy), Hydrocephalus or intracranial masses on CT or MRI. findings without evidence of thrombosis; lumbar puncture opening pressure of >25 cmH2O; normal biochemical and cytological composition of the CSF. The overall age-adjusted and gender-adjusted annual incidence is increasing and was reported to be 2.4 per 100 000 within the last decade (2002-2014).A variety of aetiologies have been suggested to explain the pathophysiology behind IIH, including meningeal inflammation, metabolic disturbances (e.g., hyper- or hypoadrenalism and hypoparathyroidism), medication effects (e.g., excess vitamin A, corticosteroids, and tetracycline), and cerebral venous hypertension.Imaging of patients with IIH is traditionally performed to exclude lesions that produce intracranial hypertension. MR imaging features of IIH include posterior globe flattening, a protrusion of the subarachnoid space in the cavum sellae (Empty Sella), distension of the preoptic subarachnoid space, enhancement of the prelaminar optic nerve, vertical tortuosity of the orbital optic nerve, and intraocular protrusion of the prelaminar optic nerve. Although these findings support the presence of elevated ICP and, thus, the diagnosis of IIH, they are not predictive of the severity of visual loss, and their absence does not exclude the diagnosis. It should not guide a specific management of patients with IIH .
The first line of treatment for IIH consists of weight loss and/or medical therapy including diuretics such as acetazolamide. When medical treatment fails, surgical options include cerebrospinal fluid (CSF) diversion via ventriculoperitoneal (VP) or lumboperitoneal (LP) shunting or optic nerve sheath fenestration. Recently, another etiology of cerebral venous hypertension has garnered increasing attention as a putative cause of IIH, cerebral venous Dural sinus stenosis. In medically refractory IIH patients with a physiologic pressure gradient across venous stenosis, cerebral venous stenting has emerged as an alternative treatment to traditional surgical approaches.
Transverse sinus stenosis can be seen in 2 morphologic forms: an extrinsic smooth gradually narrowing tapered stenosis and intrinsic discrete obstructions, presumably due to arachnoid granulations or fibrous septae. While intrinsic transverse sinus stenosis might cause IIH by completely occluding the transverse sinus, the extrinsic compression resolves with CSF drainage. might be secondary to intracranial hypertension. Venous sinus stenting (VSS) reduces intracranial venous pressures and improves idiopathic intracranial hypertension (IIH) symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dural Venous sinus stent | Experimental | Procedure: Dural venous sinus stenting40 Patients Diagnosed with idiopathic intracranial hypertension according to modified Dandy Criteria subjected to Dural venous sinus stenting |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 40 Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH).
Key exclusion criteria (5 listed)
- Age less than or equal to 18 years.
- severe allergic reaction to iodine contrast or chronic Kidney disease.
- contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis
- patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
- pregnancy.
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 |
|---|---|---|
| Dural venous sinus stenting40 patients with idiopathic intracranial hypertension according to Modified Dandy Criteria will subjected to Dural venous stenting | Procedure or surgery | Dural Venous sinus stent |
Primary outcome
change in headache impact scale(HIT-6)
Time frame: 3, 6 months
The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function. minimum score 36 and maximum score 78
Papilledema Friesen grading scale
Time frame: 3 months and 6 months
The Frisen grading system is an objective criteria used to describe the degree of papilledema, which is swelling of the optic disc from increased ICP grading from zero to 5
Visual filed Assessment Perimetry
Time frame: 3,6 months
Perimetry is the systematic measurement of visual field function (the total area where objects can be seen in the peripheral vision while the eye is focused on a central point).
Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration
Time frame: 3,6 months
changes in other symptomology including tinnitus ,abducent nerve palsyand TVO
4 secondary outcomes
Stent Patency and pressure change
Time frame: 6 months
stent Patency
Time frame: 6 months
Safety outcome measures
Time frame: 10 days
Quality of life improvement
Time frame: 3,6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Results publication: PubMed 39209429Hilvert AM, Gauhar F, Longo M, Grimaudo H, Dugan J, Mummareddy N, Chitale R, Froehler MT, Fusco MR. Venous sinus stenting versus ventriculoperitoneal shunting: comparing clinical outcomes for idiopathic intracranial hypertension. J Neurointerv Surg. 2024 Nov 22;16(12):1264-1267. doi: 10.1136/jnis-2024-022174.
- Results publication: PubMed 14872049McGonigal A, Bone I, Teasdale E. Resolution of transverse sinus stenosis in idiopathic intracranial hypertension after L-P shunt. Neurology. 2004 Feb 10;62(3):514-5. doi: 10.1212/wnl.62.3.514. No abstract available.
- Results publication: PubMed 15230741Subramaniam RM, Tress BM, King JO, Eizenberg N, Mitchell PJ. Transverse sinus septum: a new aetiology of idiopathic intracranial hypertension? Australas Radiol. 2004 Jun;48(2):114-6. doi: 10.1111/j.1440-1673.2004.01269.x.
- Results publication: PubMed 28255904Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2.
- Results publication: PubMed 23883223Saindane AM, Bruce BB, Riggeal BD, Newman NJ, Biousse V. Association of MRI findings and visual outcome in idiopathic intracranial hypertension. AJR Am J Roentgenol. 2013 Aug;201(2):412-8. doi: 10.2214/AJR.12.9638.
- Results publication: PubMed 21680652Degnan AJ, Levy LM. Pseudotumor cerebri: brief review of clinical syndrome and imaging findings. AJNR Am J Neuroradiol. 2011 Dec;32(11):1986-93. doi: 10.3174/ajnr.A2404. Epub 2011 Jun 16.
- Results publication: PubMed 9754178Brodsky MC, Vaphiades M. Magnetic resonance imaging in pseudotumor cerebri. Ophthalmology. 1998 Sep;105(9):1686-93. doi: 10.1016/S0161-6420(98)99039-X.
- Results publication: PubMed 28187976Kilgore KP, Lee MS, Leavitt JA, Mokri B, Hodge DO, Frank RD, Chen JJ. Re-evaluating the Incidence of Idiopathic Intracranial Hypertension in an Era of Increasing Obesity. Ophthalmology. 2017 May;124(5):697-700. doi: 10.1016/j.ophtha.2017.01.006. Epub 2017 Feb 7.
- Results publication: PubMed 26146651Starke RM, Wang T, Ding D, Durst CR, Crowley RW, Chalouhi N, Hasan DM, Dumont AS, Jabbour P, Liu KC. Endovascular Treatment of Venous Sinus Stenosis in Idiopathic Intracranial Hypertension: Complications, Neurological Outcomes, and Radiographic Results. ScientificWorldJournal. 2015;2015:140408. doi: 10.1155/2015/140408. Epub 2015 Jun 4.
- Results publication: PubMed 12455560Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b.
- Results publication: PubMed 8309269Radhakrishnan K, Ahlskog JE, Garrity JA, Kurland LT. Idiopathic intracranial hypertension. Mayo Clin Proc. 1994 Feb;69(2):169-80. doi: 10.1016/s0025-6196(12)61045-3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural venous sinus stenting in people with Idiopathic Intracranial Hypertension (IIH), run by Assiut University at 1 site in Egypt.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed zayed Zayed, master degree (+201098099043, mzayeds1206@gmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in headache impact scale(HIT-6) (time frame: 3, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06833424, which also lists 11 linked publications.
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 Feb 2025.