Table 6.
Baseline and Follow-up Data Collection Schedule in CREST-2.
| Evaluation | Time | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit number | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 |
| Month | Baseline* | Post-Procedure** | 44-day | 4 | 8 | 12 | 18 | 24 | 30 | 36 | 42 | 48 |
| Informed Consent | X | |||||||||||
| Demographics | X | |||||||||||
| Medical History | X | |||||||||||
| Interval Medical Hx | X | X | X | X | X | X | X | X | X | X | ||
| Stroke Questionnaire (QVSS) | X | X | X | X | X | X | X | X | X | X | X | |
| Modified Rankin | X | X | X | X | X | X | X | X | X | X | X | |
| National Institutes of Health Stroke Scale (NIHSS) | X | X | X | X | X | X | X | X | X | X | X | X |
| Cognitive Testing | X | X | X | X | X | X | ||||||
| Ultrasound | X | X | X | X | X | |||||||
| CTA/MRA/CBA*** | X | |||||||||||
| Blood Pressure | X | X | X | X | X | X | X | X | X | X | X | |
| Laboratory † | X | X | X | X | X | |||||||
*
Must be collected prior to procedure or initiation of medical management therapy.
**
NIHSS to be collected 12–36 hours post procedure.
***
CBA indicates catheter-based angiogram.
†
Baseline blood tests include lipids, hemoglobin A1c, creatinine, potassium, alanine and aspartate transaminases, and creatine kinase.
NOTE: For patients who undergo CAS and prescribed ticlopidine, a complete blood count will be required at 2 weeks and 30 days per standard medical practice.