Comparing CSF shunts and dural venous sinus stents for IIH

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial compares two interventional procedures—CSF shunting (ventriculoperitoneal or lumboperitoneal) and dural venous sinus stenting (DVSS)—for adults with IIH and clinically significant papilloedema. Adults aged 18–64 who meet IIH consensus criteria with Frisén grade ≥3 papilloedema and who are suitable for both procedures are enrolled and assigned to one of the treatments. The study will collect clinical outcomes related to intracranial pressure, visual function and complications, as well as health‑care resource use to compare cost-effectiveness. Recruitment is taking place at NHS centres including Queen Elizabeth Hospital Birmingham, Bristol Eye Hospital and Southmead Hospital.

Why it matters

Who can join: the full rules

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).

Where it's running

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

Study contacts

• Study coordinator: Alexandra Sinclair, MBChB, FRCP, PhD
• Email: a.b.sinclair@bham.ac.uk
• Phone: +44 121 414 8040

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.