Stroke Stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. 20 years of age or older 2. Patients with acute stroke 24-72 hours after the last healthy check 3. Subjects with a pre-randomization NIHSS score of 6 or higher 4. Subjects with pre-onset modified Rankin Scale score of 2 or less 5. Subjects who can confirm ICA (cervical and intracranial) and M1 obstruction by MRA or CTA 6. Subjects who can undergo endovascular treatment promptly after randomization 7. Pre-allotment detailed DWI-ASPECTS (10-point scale) of 6 or more (ASPECTS are evaluated by detailed DWI-ASPECTS, which deducts points for M1-M6 with a high signal of 1/2 or more) or CT-ASPECTS of 6 or more 8. Subjects who explained this research using an explanation document and obtained written consent
Exclusion criteria
Exclusion criteria: 1. Patients who are unsuitable for endovascular treatment, such as having a history of hypersensitivity to contrast media 2. Patients with serious renal disease (not limited to those on dialysis) 3. Patients who are Lactating, or who are or may be pregnant 4. Patients who are expected to have a life expectancy of 90 days or less 5. Patients with a history of hypersensitivity to contrast media and for whom endovascular treatment is inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of independent living (mRS) 0-2 (ITT) 90 days (+- 10 days) after onset (or final confirmation of good health) (superiority) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Proportion of independent living (mRS) 0-2 (PPS) 90 days (+- 10 days) after onset (or final confirmation of good health) (superiority) -Improvement in mRS 90 days (+- 10 days) after onset (or final confirmation of good health) (ordered logistic regression analysis) (ITT, PPS, AT) (superiority) -Rate of independent living (mRS) 0-1 (ITT) 90 days (+-10 days) after onset (or final confirmation of good health) (superiority) -Rate of independent living (mRS) 0-3 (ITT) 90 days (+-10 days) after onset (or final confirmation of good health) (superiority) -Proportion of recanalization (Modified Mori Grade 3) 48+-36 hours after randomization | — |
Contacts
Nippon Medical School Hospital