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Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

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ClinicalTrials.gov Identifier: NCT05308823
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2022
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Alwathekbellah Ihab Ahmed Elsayed, Al-Azhar University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Idiopathic Intracranial Hypertension Procedure: Stent Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : July 15, 2022
Estimated Study Completion Date : September 5, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Group 1
The paients in this group will receive traditional treatment of IIH for 3 months.
Experimental: Group 2
The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent.
 Procedure: Stent
The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent
Other Name: Venous sinus stenting


Outcome Measures
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Primary Outcome Measures :
  1. Change in papillodema [ Time Frame: 3 months after intervention ]
    Frisen scale in grading of papilledema evaluation

  2. Improvement of headache [ Time Frame: 3 months after intervention ]
    Headache Impact Test (HIT-6) questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308823


Locations
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Egypt
Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
Cairo, Egypt
Sponsors and Collaborators
Al-Azhar University
Investigators
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Study Director: Mohammed Ahmed Zaki, Ass. Prof Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
More Information
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Responsible Party: Alwathekbellah Ihab Ahmed Elsayed, Doctor, Al-Azhar University
ClinicalTrials.gov Identifier: NCT05308823    
Other Study ID Numbers: 000046
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All selected patients will be assessed after 3 months for headache and papilledema by (HIT-6) questionnaire in headache evaluation and Frisen scale in grading of papilledema evaluation in addition to MRV.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alwathekbellah Ihab Ahmed Elsayed, Al-Azhar University:
Idiopathic Intracranial Hypertension stenting
Additional relevant MeSH terms:
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Intracranial Hypertension
Pseudotumor Cerebri
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases