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:

• People aged 18 years or older
• People who have had symptoms consistent with an acute ischemic stroke (a stroke caused by a blood clot blocking blood flow to the brain)
• People for whom a clot-removal procedure (mechanical thrombectomy) can be performed within 24 hours of when the stroke began
• People who were fully independent or nearly fully independent in daily life before the stroke (as measured by a standard disability scale called the mRS, with a score of 0 or 1)
• People with a stroke severity score (called NIHSS) of 6 or higher at the start of the study
• People confirmed by imaging to have a complete or near-complete blockage in one of three specific brain arteries (the internal carotid artery inside the skull, the M1 section of the middle cerebral artery, or the basilar artery), where a clot-removal procedure is possible
• People where the blocked blood vessel is at least 2.2 mm wide at the site of the blockage
• People whose brain scan results fall within a specific range on a scoring system (ASPECTS or PC-ASPECTS score of 6–10), indicating a limited amount of brain tissue damage at the time of assessment
• People (or their authorised representative) who have given written consent to participate

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who have had a severe allergic reaction to contrast dye used in imaging scans
• People who are currently taking part in another clinical study
• People with known bleeding disorders, a very low platelet count (below 50,000/µL), or deficiencies in blood-clotting factors
• People with significant kidney problems, indicated by a blood creatinine level of 3 mg/dL or higher, or a kidney filtration rate below 30 mL/min
• People whose life expectancy is less than 6 months, or who have cancer that has spread to other parts of the body
• People whose symptoms suggest a specific type of brain bleed (subarachnoid haemorrhage), even if brain scans appear normal
• People suspected of having a tear in the body's main artery (aortic dissection)
• People with a known condition in a blood vessel leading to the brain that would block access to the clot or make it unsafe to use the study device (for example, severe narrowing or a blockage in the neck portion of the internal carotid artery)
• People where there is a strong suspicion that the blockage is caused by a disease affecting the arteries inside the skull (intracranial arterial disease), based on imaging results
• People with evidence of a tear (dissection) in arteries in the neck or inside the skull
• People with evidence of bleeding inside the skull on a CT or MRI scan
• People with evidence of a brain tumour or significant pressure/swelling in the brain on imaging (except for small, symptom-free meningiomas of 3 cm or less)
• People suspected of having inflammation of brain blood vessels (cerebral vasculitis) or a heart valve infection (infective endocarditis)
• People with a pre-existing neurological or psychiatric condition that would make it difficult to accurately assess stroke-related outcomes — for example, dementia being treated with a specific class of medication (confirm with trial site)
• People whose medical history or imaging suggests the artery blockage has been present for a long time rather than being a new, acute event
• People whose blood vessels are too curved or twisted, or whose target vessel is too small, to safely use the specific aspiration catheters involved in this study
• People who have a previously placed stent (a small mesh tube) inside the skull in the same artery being treated, which could make it unsafe to use the study devices
• People with blockages in more than one brain artery territory, or clinical signs of strokes in multiple areas of the brain
• People with a known bulging blood vessel (aneurysm) at or near the area being treated
• People with a blood sugar level that is very low (below 50 mg/dL) or very high (above 400 mg/dL)
• People whom the treating doctor considers unsuitable for the clot-removal procedure based on their imaging results

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