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. 2014 Oct 30;15:423. doi: 10.1186/1745-6215-15-423

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

1Peripheral angiogram (procedural/post-procedure) for all patients.

2Aspirin ≥75 mg daily must be given for a minimum of 2 months, and clopidogrel 75 mg daily to be taken throughout the length of the study (2 years) post-procedure.

CT, computed tomography.

MRA, magnetic resonance angiogram.