Trial Detail

Trial detail header sampleThe aim of the IIH Intervention study is to compare dural venous sinus stenting (DVSS) with cerebrospinal fluid (CSF) shunting in terms of effectiveness to prevent sight loss

Design

We will conduct a UK multicentre randomised control trial investigating the effectiveness of dural venous sinus stenting (DVSS) compared to cerebrospinal fluid (CSF) shunting in the treatment of Idiopathic Intracranial Hypertension (IIH).

The study will be open to adults aged between 18 and 64 years with a confirmed diagnosis of IIH and at risk of permanent visual loss requiring urgent intervention to prevent blindness.

Setting

Suitable patients will be identified at NHS Trusts across the country. Participants randomised to the dural venous sinus stenting (DVSS) arm will be allocated to an Interventional Neuroradiologist for their procedure. Participants randomised to the cerebrospinal fluid (CSF) shunting arm will be allocated to a neurosurgeon for their procedure.

Target population

  • Adults with diagnosis of Idiopathic Intracranial Hypertension (IIH) by the IIH consensus guideline with papilloedema and at risk of permanent visual loss.
  • No previous surgery or intervention for IIH (no previous cerebrospinal fluid (CSF) shunt, dural venous sinus stenting (DVSS), optic nerve sheath fenestration)
  • Participants will be suitable for both CSF shunting and DVSS
  • Age 18 to <64 years at the time of consent

Interventions

This trial will compare the two most common interventions performed in the UK.

The first is called cerebrospinal fluid (CSF) shunting, which involves a procedure where a thin tube called a shunt is implanted in the body to drain brain fluid.

The second is called dural venous sinus stenting (DVSS), which involves a procedure where a metallic mesh tube called a stent is implanted inside a brain blood vessel.

Both procedures can preserve vision, and the trial aims to understand which intervention is the most effective to save the vision and the most cost-effective.

Measurement of Outcomes and Cost

There will be a battery of outcome measures including evaluations of visual function, papilledema, headache and quality of life. In addition, the complication rate and the need for revisions of each procedure will be measured.  We will also evaluate the cost effectiveness of the procedure.

Participants will be followed up for two years (and remote follow up for 10 years with NHS Digital data).

IIH Intervention: shunt or stent in people with IIH who are at risk of visual loss