Hypertension Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with Idiopathic Intracranial Hypertension (IIH) according to established medical guidelines, with swelling at the back of the eye (papilloedema) and a risk of vision loss
• People who have a certain level of eye swelling (graded 3 or higher on a standard medical scale) in at least one eye
• People aged 18 to 63 years old at the time of signing the consent form
• People who are medically suitable for, and willing to undergo, both a fluid-draining brain surgery (a type of shunt procedure) and a vein-widening procedure in the head (called DVSS)
• People who are able to read and sign a consent form agreeing to take part

Who may not be able to join:

• People who currently have a blood clot blocking the veins in the brain, seen on a brain scan
• People who have previously had surgery for IIH, including procedures on the eye nerve, brain fluid drains (shunts), or vein-widening procedures in the head
• People who have had weight-loss (bariatric) surgery within the last 3 months
• People who have a pre-existing eye condition (other than needing glasses or contact lenses) that could affect their vision in the eye(s) being studied
• People who are currently using recreational or illegal drugs (including marijuana), or who have had a problem with drug or alcohol use in the past year, as assessed by the study doctor
• People who have any other significant medical condition that the study doctor believes could put them at risk or affect the study results
• People who have taken part in another interventional clinical trial within the last 30 days before the screening visit (note: being part of an IIH database or observational study does not prevent joining)
• People who have already been enrolled in this specific trial previously
• People who are pregnant
• People who have a serious medical reason preventing them from safely taking blood-thinning medication around the time of the stenting procedure
• People whose raised brain pressure is caused by another identified medical condition (confirm with trial site)
• People with a known serious allergy to iodine-based contrast dye (used in medical imaging)
• People with a known allergy to nitinol or nickel (metals used in the stenting device)
• People who have a serious medical reason preventing them from having a general anaesthetic
• People who have been diagnosed with a blood-clotting disorder (such as Factor V Leiden, Protein C or S deficiency, or certain antibody conditions)
• People who currently need to take strong blood-thinning medication for another medical condition, such as an irregular heartbeat, artificial heart valves, or a blood clot history
• People who have had a non-injury-related bleed inside the brain at any point in the past
• People who have had a blood clot in a deep vein or in the lungs within the last 24 months
• People with a history of severe narrowing of the carotid arteries (major blood vessels in the neck)
• People with heart failure, an enlarged heart, or a heart condition from birth that the study doctor considers to carry a high risk of clotting
• People who currently have, or within the last 24 months have had, a symptomatic abnormal blood vessel structure in the brain
• People whose brain vein anatomy would make the catheter and stenting procedure unsafe to perform (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.