IIH Intervention: A Clinical Trial Comparing 2 Treatments (Shunts and Stents) Evaluation Of Clinical Effectiveness And Cost Effectiveness

Exclusion Criteria

• •1. Presence of current venous sinus thrombosis on diagnostic brain imaging by either MRI, MRV or CTV
• •2. Previous surgery for IIH including, optic nerve sheath fenestration, CSF shunting procedures, sub-temporal decompression and DVSS.
• •3. Previous bariatric surgery within the last 3 months
• •4. Patients with a past ophthalmic history, except refraction error, affecting the eligible eyes (study eyes) that could affect the vision.
• •5. Patient is, at the time of signing the informed consent, a user of recreational or illicit drugs (including marijuana) or has had a recent history (within the last year) of drug or alcohol abuse or dependence, in the opinion of the investigator.
• •6. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• •7. Have participated in any other interventional study within 30 days prior to the screening visit (of note participation in the IIH Life database or other observational studies will not prevent enrolment to this study).
• •8. Previous randomisation for treatment in the present study.
• •9. Pregnant.
• •10. Absolute or serious contraindication to standard anti-thrombotic regimen peri and post stenting.
• •11. Secondary causes of raised intracranial pressure. (Refer to Protocol appendix 3 for additional information.)
• •12. History of significant documented iodine-based contrast allergy.
• •13. History of documented allergy to nitinol or nickel.
• •14. Absolute or serious contraindication for general anaesthesia.
• •15. Previous diagnosis of a hypercoagulable state (Factor V Leiden, Protein C or S deficiency, Anticardiolipin antibodies, Lupus anticoagulant, B2-glycoprotein-1 antibodies, or Hyperhomocysteinaemia).
• •16. Currently requiring full anticoagulation for other medical reasons, such as atrial fibrillation, artificial valves, deep vein thrombosis or pulmonary embolism.
• •17. Documented prior non-traumatic intracranial haemorrhage.
• •18. History of deep vein thrombosis or pulmonary embolism (within the last 24 months).
• •19. History of severe carotid atherosclerotic disease.
• •20. History of heart failure, dilated cardiomyopathy or congenital heart disease, etc. that are assessed as at high thrombotic risk.
• •21. Presence of intracranial vascular malformation considered clinically symptomatic (current or within 24 months).
• •22. Anatomical anomaly of the venous sinus which would prevent safe catheterisation and stenting (e.g. multi-channel sinus).