Stroke 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:

• You are between 40 and 80 years old
• You have been diagnosed with a severe narrowing (70–99%) of the main artery in your neck (called the internal carotid artery) that has been confirmed by a scan, and you have no symptoms from it
• The artery on the opposite side of your neck has less than 70% narrowing
• You have not had a mini-stroke (TIA) or stroke related to the affected artery in the past 6 months
• You have chosen not to have a surgical procedure called carotid endarterectomy (an operation to clear the blocked artery)
• You are willing and able to attend follow-up appointments for 12 months
• You (or your legal representative) have signed a form agreeing to take part in the trial

Who may not be able to join:

• You have had symptoms caused by the narrowed neck artery within the past 6 months
• You have had a bleed inside the brain within the past year
• You have a brain aneurysm (a bulge in a blood vessel) larger than 5 mm that cannot be treated before or during this trial
• You have a completely blocked artery with no noticeable symptoms of reduced blood flow to the brain
• You have ongoing or lasting neurological problems (such as weakness, numbness, or speech difficulties) that look like they were caused by a mini-stroke or stroke
• The narrowing is located at the very beginning of the main neck artery (common carotid artery)
• You have both a narrowed neck artery and a severely narrowed artery on the same side inside the brain
• You have severe dementia
• You have a tear in the wall of the internal carotid artery (called a dissection)
• You have an aneurysm (bulge) in the internal carotid artery
• You have had a heart attack within the last 30 days
• You have poor heart function, including a very low pumping ability (ejection fraction below 30%), severe heart failure symptoms, or unstable chest pain at rest with abnormal heart test results
• You have a heart condition that causes blood clots to form and travel to the brain, such as certain heart valve problems, heart muscle disease, or infection of the heart valves
• You have certain other heart conditions, including a narrowed mitral valve, a hole between the heart's upper chambers, or a benign tumour in the heart (confirm with trial site)
• You have two or more significantly narrowed major heart arteries (70% or more) that have not been or cannot be treated
• You have blood clotting problems, very low platelet levels, or take blood-thinning medication that cannot be safely managed for this procedure
• You have very poorly controlled diabetes with extremely high blood sugar levels
• You have a serious illness such as cancer or severe breathing problems, and your life expectancy is less than 5 years
• You have severe liver or kidney problems shown by significantly abnormal blood test results
• You are allergic to the contrast dye used in scans
• You need another operation requiring general anaesthesia at the same time as this procedure
• You are pregnant or breastfeeding
• You are currently taking part in another clinical trial involving a drug or medical device
• The trial doctor does not consider you suitable for this study for other medical reasons

Imaging-related reasons you may not be able to join:

• Your aorta (the large artery from your heart) has a specific shape (called Type III arch) that makes the procedure more difficult or risky
• The large arteries leading to your neck are too curved or twisted to safely place the necessary equipment
• The internal carotid artery in your neck is too curved or twisted to safely insert the protective device or stent used in this procedure
• There is a narrowing in another nearby artery that is equal to or worse than the narrowing being treated
• The narrowed area in your artery has a very thick, hard calcium deposit around it that may make the procedure unsafe (this is checked even more carefully if you are 70 or older)

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