Acute large vessel occlusive stroke
Conditions
Interventions
Intraarterial thrombolysis group:Intraarterial TNK
Sponsors
The 2nd Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older; 2.The time from onset to randomization was within 24 hours; 3.Large vessel occlusive stroke in the anterior circulation confirmed by CTA/MRA and the vessel responsible for the signs and symptoms of acute ischemic stroke; 4.NIHSS score= 6 based on NCCT when the time of onset-to-puncture =6h; 6.when the time of onset-to-puncture beyond 6 hours and extended up to 24 hours, Alberta Stroke Program Early Diagnosis (ASPECTS) score >= 7 based on NCCT or meet the DAWN and DEFUSE-3 enrolment criteria (Patients were eligible if they had an initial infarct volume (ischemic core) of less than 70 ml, a ratio of volume of ischemic tissue to initial infarct volume of 1.8 or more, and an absolute volume of potentially reversible ischemia (penumbra) of 15 ml or more. Group A were 80 years of age or older, had a score of 10 or higher on the National Institutes of Health Stroke Scale (NIHSS); 7.scores range from 0 to 42, with higher scores indicating a more severe deficit), and had an infarct volume of less than 21 ml; 8.those in Group B were younger than 80 years of age, had a score of 10 or higher on the NIHSS, and had an infarct volume of less than 31 ml; 9.and those in Group C were younger than 80 years of age, had a score of 20 or higher on the NIHSS, and had an infarct volume of 31 to less than 51 ml.); 10.Successful endovascular thrombectomy (eTICI 2c-3); 11.Written informed consent signed by patients or their family members;
Exclusion criteria
Exclusion criteria: 1.Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI); 2.Treated by intravenous thrombolysis; 3.Prestroke mRS score >=2; 4.Intraoperative DSA angiography suggests vessel penetration, entrapment, and extravasation of contrast medium; 5.Pregnant or lactating women; 6.Allergic to contrast agents; 7.Current participation in another clinical trial; 8.Systolic pressure greater than 185 mmHg or diastolic pressure greater than 110 mmHg after aggressive treatment; 9.Genetic or acquired bleeding disposition with anticoagulation factor deficiency;or already taking oral anticoagulants and INR > 1.7; 10.Blood glucose 22.2 mmol/L (400 mg/dl), platelets 220µmol/L (2.5mg/dl)); 13.Any terminal illness with a life expectancy of less than 6 months; 14.Unlikely to be available for 90-day follow-up; 15.Intracranial aneurysm, arteriovenous malformation; 16.Brain tumors with occupying effect on imaging; 17.Puncture to recanalization time >90min; 18.Total pass numbers>3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mRS score 0 to 1 at 90 days;Symptomatic intracerebral hemorrhage (sICH) rate within 48 h and mortality at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-5L at 90 days;Proportion of patients with functional independence (mRS score 0 to 2) at 90 days;Shift in the distribution of mRS scores at 90 days;The change of the NIHSS score at five to seven days or discharge if earlier from baseline; | — |
Countries
China
Contacts
Public ContactChen Yangmei
The 2nd Affiliated Hospital of Chongqing Medical University
Outcome results
None listed