Ischemic Stroke
Conditions
Interventions
Endovascular treatment plus Bridging Intra-Arterial Thrombolysis with Tenecteplase Group:Endovascular treatment plus Bridging Intra-Arterial Thrombolysis with Tenecteplase
Endovascular treatment :Endovascular treatment
Sponsors
Baotou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. The time from onset to randomization is within 24 hours; 3. Intracranial large vessel occlusive stroke confirmed by CTA/MRA/DSA and responsible for the signs and symptoms of acute ischemic stroke; 4. ASPECTS/pcASPECTS score>=6 points; 5. eTICI<=2b67 after endovascular treatment; 6. Patients or family members sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Intracranial hemorrhage confirmed by head CT or MRI; 2. Pre-onset mRS score >=2 points; 3. Intraoperative DSA contrast showed vascular perforation and contrast agent extravasation; 4. Pregnant or lactating women; 5. Allergy to contrast agents; 6. Participating in other clinical trials that affect the results of this trial; 7. Systolic blood pressure > 185mmHg or diastolic blood pressure >110mmHg, and antihypertensive drugs cannot be controlled; 8. Genetic or acquired bleeding constitution, lack of anticoagulant factors; or have taken oral anticoagulants with INR>1.7; 9. Blood glucose 400mg/dl (22.2mmol/L), platelet 220µmol/L (2.5mg/dl)); 13. Life expectancy < 6 months due to any other disease; 14. Expected to be unable to complete follow-up; 15. Intracranial aneurysm or arteriovenous malformation at risk of bleeding; 16. Brain tumors with mass effect on imaging; 17. The number of mechanical thrombic removal brackets exceed 5 times; 18. Patients who underwent intravenous thrombolysis before surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with 90-day mRS 0-1 (%);All-cause mortality at 90 days;Symptomatic intracranial hemorrhage (SICH) within 48 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vascular recanalization grading (eTICI grading);Changes of 90-day mRS Score;Proportion of patients with 90-day mRS 0-2 (%);Proportion of patients with 90-day mRS 0-3 (%);Proportion of patients with 90-day mRS 0-4 (%);Changes of one-year mRS Score (shift analysis);90-day EQ-5D utility index score;Incidence of asymptomatic intracranial hemorrhage within 48 hours;Systemic bleeding complications (including gastrointestinal bleeding, urethral bleeding, oral or nasal mucosal bleeding, and subcutaneous hematoma);Incidence of non hemorrhagic serious adverse events (including cerebral herniation, pneumonia, respiratory failure, circulatory failure, stress ulcer, secondary epilepsy, urinary tract infection, sepsis, renal failure, acute coronary syndrome, venous thrombosis, and psychiatric symptoms);Proportion of patients with 1-year mRS 0-1 (%);Proportion of patients with 1-year mRS 0-2 (%);Proportion of patients with 1-year mRS 0-3 (%);Proportion of patients with 1-year mRS 0-4 (%);Proportion of patients with 5-year mRS 0-1 (%);Proportion of patients with 5-year mRS 0-2 (%);Proportion of patients with 5-year mRS 0-3 (%);Proportion of patients with 5-year mRS 0-4 (%);Changes of 5-year mRS Score (shift analysis);Incidence of malignant cerebral edema within 48 hours postoperatively;Procedure- and device-related complications (including arterial rupture, arterial dissection, implantation failure, stent fracture, vascular access site complications, vasospasm, and device malposition);Change in NIHSS score at 24 hours postoperatively;1-year EQ-5D utility index score;5-year EQ-5D utility index score; | — |
Countries
China
Contacts
Public ContactChangchun Jiang
Baotou Central Hospital
Outcome results
None listed