Ischaemic strokes (those caused by blockage in an artery in the brain caused by a blood clot) can be treated with very early use of clot-busting (thrombolytic) drugs to attempt to restore the blood supply and limit the damage, resulting in an increased proportion of people making a recovery to independence after stroke. However, drug treatment only succeed in restoring blood flow in a minority of people with clots in the larger arteries (10-25% depending on the size of the blood vessel) and these people also have the most severe strokes and highest risk of death or dependence as a result of the stroke. Current best treatment is therefore least effective in the group with the most severe strokes. Devices that can be fed through the blood vessels to either remove or break up the blood clot in the brain vessels can open this type of large artery blockage. However, using these devices is a highly skilled procedure and it takes some time both to set up the necessary facilities (including anaesthetic, nurses and medical support) and to reach the blockage. The extra time that is required to use these devices may mean that brain tissue is already irreversibly damaged. If so, then an individual patient cannot benefit and indeed may be harmed by opening the artery. There are no completed clinical trials comparing the outcome in people treated with standard stroke treatment and those treated with devices. PISTE is a randomised, controlled trial to test whether additional mechanical thrombectomy device treatment improves functional outcome in patients with large artery occlusion who are given IV thrombolytic drug treatment as standard care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
All patients receive IV alteplase
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
modified Rankin Scale
The proportion with favourable functional outcome defined as mRS 0-2 at 90 (+/-7) days based on the modified Rankin scale structured interview
Time frame: Day 90 +/-7
modified Rankin Scale
Full neurological recovery (mRS 0-1 versus 2-6)
Time frame: Day 90+/-7
Mortality
Time frame: Day 90 +/-7
modified Rankin Scale
Change in distribution of mRS scores adjusted for baseline variables
Time frame: Day 90 +/-7
NIH Stroke Scale (NIHSS)
Early major neurological improvement of 8 or more points, or return to NIHSS total score of 0 or 1, at 72 hours (or discharge if earlier)
Time frame: 72 hours
Angiographic patency
Angiographic patency at 22-36 hours (Core lab assessed), using CTA or MRA
Time frame: 22-36 hours
Immediate recanalisation rate
Immediate (i.e. end of procedure) recanalisation rates in subjects undergoing interventional procedures (core lab assessed).
Time frame: End of procedure
Home Time
Days spent at home between stroke and day 90
Time frame: Day 90 +/-7
Symptomatic intracranial haemorrhage
Symptomatic intracranial haemorrhage rates defined as local or remote parenchymal haemorrhage type 2 (PH2 or PHr2 ICH by ECASS 2 definition) on the 22-36 h post-treatment imaging scan, combined with a neurological deterioration of 4 points or more on the NIHSS from baseline, or from the lowest NIHSS value between baseline and 24 h, or leading to death (SITS-MOST definition)
Time frame: 22-26h
Intracranial haemorrhage
Any intracranial haemorrhage on 22-36h CT or MRI
Time frame: 22-36 hours
Significant extracranial bleeding
Extracranial bleeding, groin haematoma requiring evacuation / surgery or transfusion
Time frame: Up to day 90
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