Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Not Applicable

• Conditions: Idiopathic Intracranial Hypertension
• Interventions: Procedure: Stent

• Registration Number: NCT05308823
• Lead Sponsor: Al-Azhar University

Brief Summary

The aim of the work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema.

Detailed Description

Participants The study will include group of patients with an established diagnosis of idiopathic intracranial hypertenton meeting our inclusion criteria and will admitted to Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria) after informed consent from them. The recruitment will take place after approval from the Ethics Committee and the University Council.

* They are selected according to The modified Dandy Criteria to Diagnose IIH:

1. Grade II paplledema .

2. normal neurological examination except for six nerve palsy.

3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI.

4. normal CSF composition.

5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults (7).

* Exclusion criteria included:

1. Age less than orequal to 18 years.

2. creatinine .1.5 mg/dL.

3. severe allergic reaction to iodine contrast.

4. contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome.

5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.

6. pregnancy.

7. Blood pressure must be measured to exclude malignant hypertension, as defined as a diastolic blood pressure greater than or equal to 120 mm Hg or systolic blood pressure greater than or equal to 180 mm Hg(17).

Study Timeline

• Study First Submitted: 2022-02-11
• Study Start: 2022-03-15
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-01
• Last Update Submitted: 2022-04-01
• Study First Posted: 2022-04-04
• Last Update Posted: 2022-04-04
• Primary Completion: 2022-07-15
• Study Completion: 2022-09-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1. Grade II paplledema . 2. normal neurological examination except for six nerve palsy. 3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI. 4. normal CSF composition. 5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults

Exclusion Criteria

• 1. Age less than to 18 years. 2. creatinine .1.5 mg/dL. 3. severe allergic reaction to iodine contrast. 4.contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome. 5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. 6. pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Stent	The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent.

Primary Outcome Measures

Name	Time	Method
Improvement of headache	3 months after intervention	Headache Impact Test (HIT-6) questionnaire.
Change in papillodema	3 months after intervention	Frisen scale in grading of papilledema evaluation

Trial Locations

Locations (1)

Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria); 🇪🇬 Cairo, Egypt