Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2022-09-05

Brief Summary

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

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Detailed Description

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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).

Conditions

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Idiopathic Intracranial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

The paients in this group will receive traditional treatment of IIH for 3 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

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

Group Type EXPERIMENTAL

Stent

Intervention Type PROCEDURE

The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent

Interventions

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Stent

The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent

Intervention Type PROCEDURE

Other Intervention Names

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Venous sinus stenting

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No