Clinical trial NCT05308823: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Intracranial Hypertension
Keywords: Idiopathic Intracranial Hypertension stenting
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in papillodema
timeFrame: 3 months after intervention
measure: Improvement of headache
timeFrame: 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
Study officials:
affiliation: Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)
name: Mohammed Ahmed Zaki, Ass. Prof
role: STUDY_DIRECTOR
References: