Table 1.
Summary of measurement items and point of data capture
| Point of data capture | Pre-procedure | During procedure |
Post-procedure |
|||||
|---|---|---|---|---|---|---|---|---|
| 24 hours | Discharge | 30 days | 90 days | 6 months | 1 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 | √ | √ | √ | √ | √ | √ | √ | |
1. Physical examination: height, weight, and neurological presentation.
2. Vital signs: systolic pressure, diastolic pressure and heart rate.
3. Blood biochemistry tests: fasting blood glucose, blood urea nitrogen, TBIL, and serum creatine.
4. Blood lipid tests: total cholesterol, triglycerides, and low density lipoprotein.
5. Pregnancy tests: restricted to women with suspected pregnancy.
6. DSA examination: angiographic images will be sent to an independent laboratory for data analysis.