Acute large vessel occlusion
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Acute cerebral infarction patient 2) Patients's age => 18 3) Patients with NIHSS => 6 4) Prestroke Modified Rankin Score 0-1 5) ICA or M1 Occlusion on CT angiography or MR angiography 6) ASPECTS 3-5 or DWI-ASPECTS 3-5 7) Randamization can be finished within 6 hours from last known well time, or 6 to 24 hours from last well known well time without positive lesion on MRI-FLAIR image. 8) Endovascular treatment can be initiatedwithin 60 minutes from randomization 9) Patient or Legally Authorized Representative has signed the Informed Consent form
Exclusion criteria
Exclusion criteria: 1) Significant mass effect with midline shift 2) Known allergy to contrast agents 3) Evidence of acute intracranial hemorrhage 4) Pregnant 5) Clinical evidence of chronic occlusion 6) High risk of hemorrhage (platelet < 40,000/ul, APTT > 50 second or PT-INR > 3.0) 7) Participating in any other therapeutic investigational trial 8) Subjects who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified Rankin Scale 0-3 at 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) modified Rankin Scale 0-2 at 90 days 2) modified Rankin Scale 0-1 at 90 days 3) Distribution of patients across the ordinal modified Rankin scale 4) NIHSS improvement 8 points or more at 48 hours Safety outcome 1) Symptomatic intracranial hemorrhage within 48 hours 2) Intracranial hemorrhage within 48 hours 3) Death 4) Recurrence of cerebral infarction within 90 days 5) Decompressive craniectomy within 7 days | — |
Countries
Japan
Contacts
Hyogo College of Medicine Department of Neurosurgery