Visit 1 Baseline and randomization | Visit 2 (maximum 24 h before CEA) | Allocation (during CEA) | Visit 3 (24–48 h after CEA) | Visit 4 (30 ± 2 days after CEA) | Visit 5 (365 ± 14 days after CEA) | |
---|---|---|---|---|---|---|
Medical and surgical history | X | X | X | X | X | |
Demographics | X | |||||
Physical examination | X | X | X | X | X | |
Vital signs | X | X | X | |||
Neurological examination | X | X | X | X | X | |
NIHSS | X | X | X | X | X | |
mRS | X | X | X | X | X | |
Duplex sonography | X | X | X | X | X | |
CTA, MRA or DSA | X | |||||
Signed informed consent | X | |||||
Eligibility criteria | X | |||||
MRI (for substudy only) | X | X (24 ± 4 h) | ||||
ACE-R | X | X | X | X | ||
MMSE | X | X | X | X | ||
Clock-drawing Test | X | X | X | X | ||
Verbal Fluency Test | X | X | X | X | ||
Sonolysis | X | |||||
Sham procedure | X | |||||
Adverse event, SAE | X | X | X | |||
Endpoints | X | X | X |