Point of data capture | Pre-procedure | During procedure | Post-procedure | |||||
---|---|---|---|---|---|---|---|---|
24Â hours | Discharge | 30Â days | 90Â days | 6Â months | 1Â year | |||
Window phase |  |  |  |  | ±7 d | ±15 d | ±30 d | ±30 d |
Informed consent form | √ |  |  |  |  |  |  |  |
Inclusion/exclusion criteria | √ |  |  |  |  |  |  |  |
Withdrawal criteria |  | √ |  |  | √ | √ | √ | √ |
Medical history/demographic information | √ |  |  |  |  |  |  |  |
Physical examination (1) | √ |  |  | √ |  |  | √ |  |
Vital signs (2) | √ | √ |  | √ |  |  |  |  |
Routine urine and blood test | √ |  |  | √ |  |  |  |  |
Blood biochemistry test (3) | √ |  |  | √ |  |  |  |  |
Blood lipid test (4) | √ |  |  |  |  |  |  |  |
Pregnancy tests (5) | √ |  |  |  |  |  | √ |  |
CTA, MRA or DSA | √ |  |  |  |  |  |  |  |
Clinical evaluation |  | √ |  |  | √ | √ | √ | √ |
DSA examination (6) |  | √ |  |  |  |  | √ |  |
Adverse events |  | √ | √ | √ | √ | √ | √ | √ |