Table 1 Study schedule
Procedure/Test | Baseline (within 60 days) | Procedure | 4 weeks (±2 weeks) office visit | 6 months (±1 month) | 12 months (±1 month) office visit | 24 months (±1 month) office visit | Unschedul d visits |
|---|---|---|---|---|---|---|---|
Patient medical/Clinical history | ✓ | ||||||
Patient informed consent (for Swiss centers) | ✓ | ||||||
General inclusion/Exclusion criteria | ✓ | ||||||
Rutherford classification | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Quality of life questionnaire | ✓ | ✓ | ✓ | ✓ | |||
Preoperative angiography, CT scan or MRA | ✓ | ||||||
Angiographic/Anatomic inclusion/exclusion criteria | ✓ | ||||||
Peripheral angiogram with runoff | ✓1 | ||||||
Ankle brachial index (ABI)/Toe brachial index if ABI >1.3 or not able to be reliably measured | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Duplex ultrasound | ✓ | ✓ (within the first 4 weeks) | ✓ | ✓ | ✓ | ||
Stent radiography | ✓ | ✓ | ✓ | ||||
Per protocol medications2 | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Concomitant medications | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Adverse events/Device deficiencies/Adverse product experiences | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |