Summary of study assessments
Assessment/steps | Screening and enrolment period | Postrandomisation treatment period | Visiting period | |
0 hours–24 hours | 1 day | 2 days–1 week | 90, 180, 360 days | |
Signed informed consent | X | |||
Review of inclusion/exclusion criteria | X | |||
Basic information | X | |||
Medical history | X | |||
Cholesterol | X | X | X | |
mRS | X | X | ||
NIHSS | X | X | X | |
GCS | X | X | X | |
Routine blood test | X | X | ||
Blood biochemistry | X | X | ||
Coagulation | X | X | ||
Cranial CT | X | X | ||
CTA | X* | X* | X | |
MRA | X* | X* | ||
Electrocardiography | X | |||
DWI | X | X | ||
DSA imaging | X* | X* | X* | |
Medication | X | X | X | |
Symptomatic intracranial haemorrhage | X | |||
Asymptomatic intracranial haemorrhage | X | |||
Reocclusion | X | X | X | |
Dead | X | X | X | |
Adverse event | X | X | X | |
Complications (undesired side-effect of medical procedure) | X | X | X | |
Debridement flap decompression | X | X | ||
Clinical study completion |
*CTA, MRA or DSA may be used during the screening period and the late 1 week of randomisation; CTA/MRA may be used for follow-up during postrandomisation treatment.
CTA, CT angiography; DSA, digital subtraction angiography; DWI, diffusion weight image; GCS, Glasgow Coma Scale; MRA, magnetic resonance angiography; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale Scores.