A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
380
intra-arterial tenecteplase during endovascular treatment
General Hospital of Northern Theater Command
Shenyang, China
proportion of favorable outcome
Favorable outcome is defined as modified Rankin Scale (mRS) score of 0-2
Time frame: Day 90
proportion of excellent outcome
Excellent outcome is defined as modified Rankin Scale (mRS) score of 0-1
Time frame: Day 90
proportion of successful reperfusion after the first-pass or final pass of endovascular treatment
Successful reperfusion is defined as defined as modified Thrombolysis In Cerebral Infarction (mTICI) 2b-3
Time frame: immediately after the first-pass or final pass of endovascular treatment
Distribution of modified Rankin Scale (mRS)
mRS scores range from 0 to 6:0, no symptoms, 1 = symptoms without clinically significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability; and 6 = death.
Time frame: Day 90
Change in cerebral circulation time after intervention
Time frame: immediately after endovascular treatment
occurrence rate of early neurological improvement
early neurological improvement was defined as a 4 point or greater decrease in NIHSS
Time frame: 24 (-6/+24) hours
change in National Institute of Health stroke scale (NIHSS)
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Time frame: 24 (-6/+24) hours
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occurrence rate of the composite events of nonfatal stroke, nonfatal myocardial infarction, and other cardiovascular events
Time frame: Day 90
occurrence rate of symptomatic intracranial hemorrhage
symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage.
Time frame: 24 (-6/+24) hours
occurrence rate of parenchymal hemorrhage
parenchymal hemorrhage was defined as confluent bleeding occupying and causing mass effect
Time frame: 24 (-6/+24) hours
percentage of severe adverse events
Time frame: 24 (-6/+24) hours
cerebral edema
cerebral edema was measured as the amount of midline shift of the brain on neuroimaging
Time frame: 24 (-6/+24) hours
death due to all causes
Time frame: Day 7 or during hospitalization
occurrence rate of the distal emboli after first pass
The emboli means occlusion of the distal artery determined by DSA.
Time frame: immediately after first pass
occurrence rate of extracranial hemorrhage
extracranial hemorrhage means other bleeding events except intracranial hemorrhage
Time frame: 24 (-6/+24) hours