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Clinical Trials/NCT05308823
NCT05308823UnknownNot Applicable

Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Al-Azhar University1 site in 1 country20 target enrollmentStarted: March 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
Improvement of headache

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •1. 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

Exclusion Criteria

  • •1. Age less than to 18 years.
  • •creatinine .1.5 mg/dL.
  • •severe allergic reaction to iodine contrast. 4.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.

Arms & Interventions

Group 1

No Intervention

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

Group 2

Experimental

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

Intervention: Stent (Procedure)

Outcomes

Primary Outcomes

Improvement of headache

Time Frame: 3 months after intervention

Headache Impact Test (HIT-6) questionnaire.

Change in papillodema

Time Frame: 3 months after intervention

Frisen scale in grading of papilledema evaluation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alwathekbellah Ihab Ahmed Elsayed

Doctor

Al-Azhar University

Study Sites (1)

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