Patients presenting to the emergency department with acute ischaemic stroke, who are eligible for standard intravenous tPA therapy within 4.5 hours of stroke onset will be assessed for "dual target" major vessel occlusion and mismatch to determine their eligibility for randomisation into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to intra-arterial clot retrieval after IV tPA or IV tPA alone. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours.
Standard care IV tPA therapy administered as per registered product information
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Western Hospital
Melbourne, Victoria, Australia
Reperfusion at 24 hours (CT or MR perfusion imaging)
Time frame: 24 hours post stroke onset
Favourable clinical response at 3 days(National Institutes of Health Stroke Score - NIHSS)
NIHSS - reduction \>/= 8 points or reaching 0-1)
Time frame: 3 days post stroke onset
Reperfusion at 24 hrs post stroke without symptomatic intracerebral hemorrhage (CT or MR perfusion imaging)
Time frame: 24 hours post stroke onset
Recanalisation at 24 hrs post stroke (CT or MR angiography)
Time frame: 24 hours post stroke onset
Infarct growth within 24 hrs (CT and MRI)
Time frame: 24 hours post stroke onset
Stroke severity (NIHSS) at 24 hours
Time frame: 24 hours post stroke onset
Symptomatic intra-cranial hemorrhage (ECASS type 2 parenchymal hematoma on CT or MRI combined with >/=4 point deterioration in NIHSS within 36 hours of treatment).
Time frame: within 36 hours of intervention
Death due to any cause
Time frame: 3 months
Modified Rankin Scale (mRS) 0-1 at 3 months
Time frame: 3 months
Categorical shift in mRS at 3 months
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Austin Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Monash Medical Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Auckland Hospital
Grafton, Auckland, New Zealand
NIHSS reduction 8 points or reaching 0-1 at 3 months
Time frame: 3 months
Modified Rankin Scale (mRS) 0-2 at 3 months
Time frame: 3 months