Phase 1 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 80 years old (including those exact ages)
• People who have had an ischemic stroke (a stroke caused by a blocked blood vessel) with a moderate-to-severe stroke severity score, measured on a standard medical scale (NIHSS score of 6–20)
• People where it is known the stroke began no more than 24 hours before being enrolled in the trial
• People who were largely independent in daily life before the stroke, with little or no disability (pre-stroke Modified Rankin Scale score of 0–1)
• People who have been assessed as suitable for clot-dissolving treatment given through a vein, a procedure to physically remove the clot, or both
• People (or their legal representative) who have signed a consent form agreeing to take part
• People whose scan (CT angiography) has confirmed a blockage in one of the main blood vessels supplying the front part of the brain
• People whose brain scan shows a score between 6 and 10 on a standard scale used to measure early stroke damage (ASPECTS score)
• People whose brain perfusion scan shows: the area of already-damaged brain tissue is less than 70ml; the area of at-risk (but potentially saveable) tissue is at least 1.8 times larger than the damaged area; and the difference between those two areas is greater than 15ml (confirm with trial site)

Who may not be able to join:

• People whose clinical signs suggest bleeding inside the brain or around the brain's surface
• People who have epilepsy
• People who are in a coma or have a mental health condition that could make it difficult to carry out standard neurological assessments
• People with a known allergy or medical reason to avoid a class of medications called phenothiazines
• People with a known allergy to iodine-based contrast dye, or who have previously had a severe allergic reaction (anaphylactic shock) to it
• People whose blood sugar level is too low (below 50mg/dL) or too high (above 400mg/dL) at the start of the trial
• People whose platelet count (cells that help blood clot) is too low (below 50×10⁹/L)
• People who have had a significant bleeding episode in the 30 days before enrolment, or who have active bleeding, abnormal clotting, or a strong tendency to bleed (confirm with trial site for specific clotting test thresholds)
• People whose stroke is accompanied by a fever, or who have an active infection that requires treatment throughout the body (such as active tuberculosis)
• People whose expected survival is less than 90 days
• People with serious heart or cardiovascular conditions, including: blood pressure that remains very high or very low after standard treatment; high blood pressure in the lungs; a heart attack, unstable chest pain, or heart bypass or stent surgery within the past 6 months; severe chronic heart failure; significant heart valve disease; or serious abnormal heart rhythms (certain types — confirm with trial site), including a prolonged electrical interval on a heart tracing (QT interval ≥450ms for men or ≥470ms for women)
• People with significant lung conditions, including chronic obstructive pulmonary disease (COPD), tuberculosis, pneumonia, collapsed lung, lung fibrosis, fluid around the lungs, or other serious lung diseases
• People with severe liver or kidney problems, including cirrhosis, liver failure, kidney failure, or related conditions
• People who are pregnant or breastfeeding
• People who are currently taking part in another clinical trial or have recently used an experimental drug or medical device
• People who, for any other reason, may not be able to complete the study, or whom the investigator does not consider appropriate for inclusion
• People whose blood vessel scans show the arteries are too curved or twisted to safely deliver the treatment devices
• People whose scans or medical history suggest inflammation of the brain's blood vessels
• People whose scans or medical history suggest a tear in the main artery from the heart (aortic dissection)
• People whose scans show blockages in multiple blood vessel areas, or clinical signs of stroke affecting more than one region of the brain
• People whose scans confirm a specific blood vessel condition called moyamoya disease or moyamoya syndrome
• People whose brain scans show significant shifting of brain structures to one side
• People whose brain scans confirm a brain tumour (other than a specific type called cerebellar meningioma) or bleeding inside the brain

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