Acute ischemic stroke
Conditions
Interventions
Experimental group:Intraarterial TNK
Control group:Standard treatment
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 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 = 7 based on NCCT or meet the DEFUSE-3 enrollment 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. DAWN enrollment criteria: group A were 80 years of age or older, had a score of 10 or higher on the NIHSS scores and had an infarct volume of less than 21 mL, 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, 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;. 6. Successful endovascular thrombectomy (eTICI 2c-3); 7. 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 patients; 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; 19. Complete return to normal after revascularization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day modified RANKIN scale (mRS) score 0-1 (%);Symptomatic intracerebral hemorrhage (sICH) rate within 48 h and mortality at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Shift in the distribution of mRS scores at 90 days;Proportion of patients with functional independence (mRS score 0 to 2) at 90 days;Score of the 90-day five-level and five-dimensional health scale (EQ-5D-5L);Changes in the national institutes of health stroke scale (NIHSS) score 5-7 days after surgery; | — |
Countries
China
Contacts
Public ContactZi Wenjie; Chen Yangmei
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed