Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Sponsor

Al-Azhar University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05308823

Collaborator

(none)

Enrollment

Location

Arms

5.7

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Intracranial Hypertension	Procedure: Stent	N/A

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).

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 15, 2022

Anticipated Primary Completion Date :

Jul 15, 2022

Anticipated Study Completion Date :

Sep 5, 2022

Arms and Interventions

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 Names: Venous sinus stenting

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 Names:

Venous sinus stenting

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

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

Locations

	Site	City	State	Country	Postal Code
1	Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)	Cairo		Egypt

Sponsors and Collaborators

Al-Azhar University

Investigators

Study Director: Mohammed Ahmed Zaki, Ass. Prof, Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alwathekbellah Ihab Ahmed Elsayed, Doctor, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05308823

Other Study ID Numbers:

000046

First Posted:

Apr 4, 2022

Last Update Posted:

Apr 4, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alwathekbellah Ihab Ahmed Elsayed, Doctor, Al-Azhar University

Idiopathic Intracranial Hypertension stenting

Additional relevant MeSH terms:

Intracranial Hypertension

Pseudotumor Cerebri

Hypertension

Study Results

No Results Posted as of Apr 4, 2022