Health TrialsbyHealthPanel

Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension

ConditionIdiopathic Intracranial Hypertension (IIH)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAssiut University

About this trial

This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

40 Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH).

Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema.

No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis.

Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities.

Disqualifiers

Age less than or equal to 18 years.

severe allergic reaction to iodine contrast or chronic Kidney disease.

contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis

patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dural venous sinus stenting

    Procedure/Surgery

    40 patients with idiopathic intracranial hypertension according to Modified Dandy Criteria will subjected to Dural venous stenting

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Dural Venous sinus stentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

change in headache impact scale(HIT-6)

The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function. minimum score 36 and maximum score 78

Time frame
3, 6 months
2

Papilledema Friesen grading scale

The Frisen grading system is an objective criteria used to describe the degree of papilledema, which is swelling of the optic disc from increased ICP grading from zero to 5

Time frame
3 months and 6 months
3

Visual filed Assessment Perimetry

Perimetry is the systematic measurement of visual field function (the total area where objects can be seen in the peripheral vision while the eye is focused on a central point).

Time frame
3,6 months
4

Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration

changes in other symptomology including tinnitus ,abducent nerve palsyand TVO

Time frame
3,6 months

Secondary outcomes

1

Stent Patency and pressure change

Diagnostic DSA follow up and measuring pressure gradient changes pre and post stenting

Time frame
6 months
2

stent Patency

in stent stenosis and Adjacent stent stenosis

Time frame
6 months
3

Safety outcome measures

Safety outcomes of occurrences of complication: Subdural Hematoma, Subarachnoid Hemorrhage, Intracerebral hematoma puncture site complication (retroperitoneal hematoma or femoral artery aneurysm)

Time frame
10 days
4

Quality of life improvement

Quality of life measure: SF-36 for fatigue.

Time frame
3,6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: