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 between 22 and 85 years of age.
• People (or their legal representative or next of kin) who have given written consent to participate.
• People who have developed a new, focused and disabling neurological problem 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 largely independent in daily life before the stroke (a pre-stroke disability score of 0, 1, or 2 on a standard scale).
• People who can begin treatment within 16 hours of when they were last seen to be well and symptom-free.
• People who have received, or are receiving, clot-dissolving medication (thrombolysis) if their treating doctors determined it was appropriate, in line with standard medical guidelines.
• People who have a confirmed blockage in a specific large brain artery (the terminal carotid artery, the main middle cerebral artery, or a major branch of it), as confirmed by specialised imaging, and where a mechanical clot-removal procedure is indicated.
• People whose brain scans meet specific imaging requirements — either showing a small area of damaged brain tissue (under 50 mL on a perfusion scan), or scoring between 6 and 10 on a standard early stroke CT scoring system (ASPECTS), with a score of 5 also considered at certain centres using MRI.
• People for whom doctors have determined that a clot-removal procedure using an approved stent retriever device is appropriate.

Who may not be able to join:

• People who have had a stroke within the past year.
• People whose symptoms suggest a stroke affecting both sides of the brain or multiple separate areas.
• People with known bleeding disorders, significant clotting problems, or who are on certain blood-thinning medications with a clotting level (INR) above 3.0, or who have a very low platelet count (below 50,000 per mL).
• People with a known blood sugar level below 50 mg/dL or above 400 mg/dL at the time of assessment.
• People with severely high blood pressure that cannot be brought under control (above 185/110 mmHg despite treatment).
• People with a serious or terminal illness where life expectancy is less than one year.
• People with a known cancer that has spread to other parts of the body.
• People with a known history of a serious allergic reaction (more than a skin rash) to contrast dye used in imaging.
• People with known significant kidney disease, indicated by a creatinine level of 3 mg/dL or higher, or a kidney filtration rate below 30 mL/min.
• People with current or recent use of cocaine and/or heroin.
• People who are known to be pregnant or breastfeeding.
• People already taking part in another clinical study involving an experimental drug or device that could affect this trial's results.
• People who are unlikely to be available for a follow-up appointment at 90 days (for example, overseas visitors or people without a fixed address).
• People whose brain scans show bleeding (though tiny microbleeds are allowed).
• People whose scans show significant brain swelling causing a shift in brain structures.
• People with evidence of a brain tumour, except for a small, non-symptomatic type called a meningioma measuring 2 cm or less.
• People where doctors suspect a torn aorta (aortic dissection), an infected blood clot, or bacterial infection of the heart valves.
• People who have a pre-existing stent near the blocked artery that could make it unsafe to use the clot-removal device.
• People whose blood vessels are too twisted or curved for the procedure to be safely performed, as determined by the treating doctor.

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