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

RecruitingNAAges 18 Years - 63 YearsAllUniversity of Birmingham
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In plain words

What the trial is, and whether it could suit you

Background and study aims Idiopathic intracranial hypertension (IIH) is a neurological condition characterised by increased pressure inside the skull, called intracranial pressure (ICP). It is more common in women of reproductive age with obesity. Common symptoms of IIH include headaches, blurred vision and ringing in the ears. If left untreated, the disorder may cause blindness. The majority of patients with IIH are managed with weight loss and medications. Fewer than 10% of patients develop progressive visual loss and require urgent intervention to reduce ICP and preserve vision. This trial will compare the two most common interventions performed in the UK and evaluate their clinical and cost-effectiveness. The first is called cerebrospinal fluid (CSF) shunting and involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid. The second is called

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis of IIH by the IIH consensus guidelines with papilloedema and at risk of visual loss. 2. Presence of papilloedema (Frisén grade ≥ 3) in at least one eye 3. Age 18 to \< 64 years at the time of consent. 4. Patients must be suitable for and willing to proceed with both CSF shunting (VP or Lumboperitoneal shunts only) and DVSS. 5. Able to provide written informed consent. 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).
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What it tests

  • CSF shunt
  • DVSS
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Where

15 sites
The Queen Elizabeth Hospital
Birmingham, United Kingdom
Bristol Eye Hospital
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Princess Alexandra Eye Pavillion
Edinburgh, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
Royal Hull Infirmary
Hull, United Kingdom

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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