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Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Primary Purpose

Idiopathic Intracranial Hypertension

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Stent
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring Idiopathic Intracranial Hypertension stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in papillodema
Frisen scale in grading of papilledema evaluation
Improvement of headache
Headache Impact Test (HIT-6) questionnaire.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2022
Last Updated
April 1, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05308823
Brief Title
Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension
Official Title
Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
September 5, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Grade II paplledema . normal neurological examination except for six nerve palsy. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI. normal CSF composition. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults (7). Exclusion criteria included: Age less than orequal to 18 years. creatinine .1.5 mg/dL. severe allergic reaction to iodine contrast. contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. pregnancy. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
Keywords
Idiopathic Intracranial Hypertension stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
The paients in this group will receive traditional treatment of IIH for 3 months.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent.
Intervention Type
Procedure
Intervention Name(s)
Stent
Other Intervention Name(s)
Venous sinus stenting
Intervention Description
The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent
Primary Outcome Measure Information:
Title
Change in papillodema
Description
Frisen scale in grading of papilledema evaluation
Time Frame
3 months after intervention
Title
Improvement of headache
Description
Headache Impact Test (HIT-6) questionnaire.
Time Frame
3 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed Ahmed Zaki, Ass. Prof
Organizational Affiliation
Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
Official's Role
Study Director
Facility Information:
Facility Name
Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

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