acute ischemic stroke
Conditions
Interventions
Group 1:IVT+EVT
Group 2:direct EVT
Sponsors
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The clinical diagnosis is AIS; 2. It was confirmed by CTA/MRA/DSA that AIS; was caused by BAO; 3. CT or MRI to exclude intracranial hemorrhage; 4. Suitable for IVT and EVT treatment (within 4.5 hours of onset); 5. NIHSS score >= 6; 6. Age >= 18 years old; 7. The patient himself or his legal representative signed a written informed consent.
Exclusion criteria
Exclusion criteria: 1. mRS score > 2 before onset; 2. According to the American Heart Association guidelines, there are any of the following IVT contraindications, namely: (1) Blood pressure > 185/110 mmHg, which cannot be controlled by standard drug treatment; (2) Blood sugar 400 mg/dl (22.2 mmol/L); (3) Suffering from cerebral infarction within the previous 6 weeks, and having neurological deficit or neuroimaging showing signs of recent infarction; (4) Has a history of major head trauma in the past 3 months; (5) Major surgery or severe trauma within the past 2 weeks; (6) Gastrointestinal or urinary system bleeding in the past 3 weeks; (7) Intracranial hemorrhage occurred in the past; (8) Use anticoagulant and INR > 1.7; (9) Known platelet count < 100 × 10^9/L; (10) Receive direct thrombin or X factor inhibitor therapy; (11) Received heparin therapy within 48 hours (APTT exceeds the upper limit of normal value); 3. Women of childbearing age who plan to become pregnant during pregnancy, lactation or during the study; 4. Other conditions that the researchers think are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with mRS <= 2 at 90 days (± 14 days); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of patients with mRS = 0 or 1 at 90±14 days after stroke onset ;Proportions of patients with mRS = 0–3 at 90±14 days after stroke onset ;Proportions of mRS score at 90±14 days after stroke onset ;NIHSS score at 18–24 hours after procedure, 24–72 hours after procedure, and 5–7 days after stroke onset and their changes from baseline;Proportions of patients with a NIHSS score = 0 or 1, a NIHSS score = 0–2, a NIHSS score improvement = 4 points, and a NIHSS score improvement = 8 points at 18–24 hours after procedure, 24–72 hours after procedure, and 5–7 days after stroke onset;GCS score at 18–24 hours after procedure, 24–72 hours after procedure, and 5–7 days after stroke onset and their changes from baseline;BI score and the proportion with BI = 95–100 at 30±7 and 90±14 days after stroke onset.;EQ-5D-5L score at 90±14 days after stroke onset;eTICI score and successful reperfusion rates before and after EVT.;mAOL score and recanalization rates at 24–72 hours after procedure.;PC-ASPECTS score at 24–72 hours after procedure;Lesion volume based on quantitative imaging detection at 24–72 hours after procedure and 5–7 days after stroke onset.;All-cause mortality within 7, 30±7 and 90±14 days after stroke onset.;Proportions of patients with intracranial hemorrhage and symptomatic intracranial hemorrhage at 24–72 hours after procedure and 5–7 days after stroke onset;Proportions of patients with embolization to new territory during EVT;Proportions of patients with new cerebral infarction at 24–72 hours after procedure and 5–7 days after stroke onset;EVT procedure-related complications within 90±14 days after stroke onset;Other serious adverse events within 90±14 days after stroke onset; | — |
Countries
China
Contacts
Public ContactFuqiang Guo
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Outcome results
None listed