Phase 3 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 or older
• People who have had an acute ischemic stroke (a stroke caused by a blocked blood vessel) due to a large vessel blockage in the front part of the brain, where clot-dissolving medication given through a vein is either not appropriate, not possible, or was tried but did not reopen the vessel
• People whose large vessel blockage has been confirmed by a CTA or MRA scan (special imaging of blood vessels), involving specific arteries in the brain (the internal carotid artery or the M1 segment of the middle cerebral artery), where a mechanical procedure to remove the clot is planned within 24 hours of when the person was last known to be well
• People with a stroke severity score (NIHSS) of 6 points or higher at the start of the trial
• People, or their family members, who have signed a written consent form agreeing to take part

Who may not be able to join:

• People whose brain scans show strokes in multiple areas of the brain supplied by different blood vessels at the same time
• People where the blood vessels needed for the procedure are not accessible — for example, due to no detectable pulse in the femoral artery (groin), extremely difficult access to blood vessels, or severely twisted large vessels
• People with very high blood pressure that is difficult to bring under control (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measured continuously on arrival)
• People who are in a coma or in a very drowsy state (a specific consciousness score of 2 or higher on the NIHSS scale)
• People where an accurate stroke severity score (NIHSS) cannot be measured at the start
• People who had some level of disability before their stroke (a pre-stroke modified Rankin Scale score greater than 1)
• People whose brain scan shows a large area of already-damaged brain tissue (ASPECTS score of 5 or lower)
• People with a tendency to bleed, a clotting factor deficiency, or who are taking blood-thinning medication with a specific clotting measure (INR) above 3.0
• People with blood sugar levels that are too low (below 2.7 mmol/L) or too high (above 22.2 mmol/L) at the start
• People with a very low platelet count (below 30 × 10⁹/L) in their blood at the start
• People with severe kidney problems who require dialysis (hemodialysis or peritoneal dialysis), or whose kidney filtering rate is known to be below 30 mL/min
• People whose brain scan (CT or MRI) shows bleeding inside the skull
• People whose brain scan shows the brain has shifted to one side or is showing significant pressure effects inside the skull
• People with a history, prior scans, or clinical signs suggesting a brain tumour, abnormal blood vessel formation in the brain (arteriovenous malformation), or a tear in an artery inside the skull
• People who have had a head injury in the past 3 months
• People with a known life-threatening allergy to contrast dye used in scans, or to nickel, titanium, or their alloys
• People who are pregnant (confirmed by a positive pregnancy test) or who are currently breastfeeding
• People whose life expectancy is less than 6 months, or who cannot be followed up and assessed within 3 months
• People with limb deformities, soft tissue injuries, or other physical conditions that would prevent a specific therapy involving controlled, temporary restriction of blood flow to a limb (remote ischaemic conditioning) from being carried out
• People who are already taking part in another ongoing clinical trial
• People whom the trial investigators consider unsuitable for any other reason (confirm with trial site)

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