Stroke Trial, Recruiting

Written by an AI model from the 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 aged between 18 and 85 years old
• People (or their legal representative or next of kin) who have given written consent to take part
• People who have developed a new, disabling neurological problem affecting one part of the body, consistent with an acute stroke caused by a blocked blood vessel
• People whose stroke severity score (called NIHSS) was between 6 and 25 before the procedure
• People who were functioning independently or near-independently before the stroke (a pre-stroke disability score of 0, 1, or 2 on a standard scale)
• People who can be treated within 24 hours of stroke symptoms starting
• People who, if clot-dissolving medication (thrombolysis) is appropriate, receive it promptly in line with recognised medical guidelines
• People whose brain scan (angiogram, CTA, or MRA) confirms a near-complete or complete blockage (eTICI score of 0 or 1) in a specific large artery in the brain — either the internal carotid artery inside the skull, or the main or upper branches of the middle cerebral artery
• People whose brain CT or MRI scan shows that only a limited area of brain tissue has been damaged so far (ASPECTS score between 6 and 10, or a core infarct volume of 50 cc or less if automated imaging assessment is used)

Who may not be able to join:

• People whose neurological symptoms are improving rapidly before enrolment, suggesting the stroke may be resolving on its own
• People who have had a stroke within the past 6 months
• People whose symptoms suggest a stroke affecting both sides of the brain or more than one blood vessel territory
• People whose symptoms suggest bleeding around the brain (subarachnoid haemorrhage)
• People with known bleeding disorders, clotting factor deficiencies, or who are on certain blood-thinning medications where a specific blood test result (INR) is above 3.0
• People with a known blood sugar level below 50 mg/dL or above 400 mg/dL at baseline
• People with severely elevated blood pressure that has not responded to treatment (above 185/110 mmHg)
• People with a serious or terminal illness where life expectancy is less than one year
• People with a known history of a severe allergic reaction (more than a skin rash) to contrast dye used in imaging
• People with a known severe sensitivity to nickel, titanium, or related metal alloys
• People with known significant kidney problems (creatinine level at or above 3 mg/dL, or kidney filtration rate below 30 mL/min)
• People who require kidney dialysis (haemodialysis or peritoneal dialysis)
• People with current or recent use of cocaine or heroin
• People who are known to be pregnant or breastfeeding
• People already participating in another clinical study involving an unapproved drug or device that could affect this trial's results
• People unlikely to be available for a follow-up appointment at 90 days (for example, those without a fixed address or who are visiting from overseas)
• People whose brain scan shows evidence of bleeding (though very small microbleeds are allowed)
• People whose brain scan shows significant swelling causing a shift of brain structures from their normal position
• People whose brain scan shows a brain tumour (except a small, symptom-free meningioma of 2 cm or less)
• People whose brain scan shows inflammation of blood vessels in the brain (cerebral vasculitis)
• People where there is a suspicion of a tear in the main heart artery (aortic dissection), an infected clot, or a heart valve infection
• People who have an existing stent near or at the blockage site that may make it unsafe to use the retrieval device
• People whose blood vessel blockage improves beyond a minimal level before the procedure begins (assessed during the procedure)
• People who were initially treated with a different thrombectomy device during the same procedure
• People whose blood vessels are too twisted or curved for safe access to the blocked artery, as judged by the treating specialist (confirm with trial site)
• People with additional blockages, severe narrowing, or artery tears in the internal carotid artery outside or inside the skull that prevent access to the clot or require separate treatment
• People where the blockage is caused by hardening and narrowing of an artery wall inside the brain (intracranial atherosclerotic disease), rather than a clot
• People with blockages in more than one brain artery territory at the same time
• People in whom arterial access cannot be established during the procedure

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