Table 1 Visits and exams Patients should be followed at regular intervals during one year after the initial percutaneous deep vein arterialization procedure in accordance with standard of care and local practice. Visits and exams scheduled for this post-market study are presented in 1 below (keys: ■ mandatory, □ optional)
Exams | Baseline | Treatment | Week 02 | Month 01 | Month 02 | Month 03 | Month 06 | Month 09 | Month 12 |
|---|---|---|---|---|---|---|---|---|---|
Eligibility | ■ | ||||||||
Demographics | ■ | ||||||||
Infection statusa | ■ | ||||||||
Venous mappingb | ■ | ||||||||
Angiogram | ■ | ■ | |||||||
Ultrasound | Duplex | Duplex | Duplex | Duplex | Duplex | Duplex | Duplex | ||
Medication | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ■ |
Creatinine | ■ | □ | □ | ||||||
Rutherford | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ||
WIfI | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ||
Wound pictures | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ■ | |
Pain | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ■ | |
Perfusion | □ | □ | □ | □ | □ | □ | □ | □ | |
Quality of Life | ■ | ■ | ■ | ■ | ■ | ||||
Adverse events | ■ | ■ | ■ | ■ | ■ | ■ | ■ | ■ |