Procedures
ABI
COMPLICATIONS
Standard procedures were followed based on the instructions for use for the devices. Intraoperative heparinization (5000 units) was applied in both treatment groups. The only pre-treatment allowed prior to placement of the ZILVER PTX stent was standard balloon angioplasty. The use of pre- and postdilation was recommended but at the physician’s discretion. Angiography immediately after the endovascular intervention was required to evaluate the postoperative lesion. Following treatment, antiplatelet therapy consisting of clopidogrel for at least 60 days and lifelong aspirin therapy was routinely prescribed. Physical examination was performed prior to discharge. The follow-up data collection points were 1, 6, 12, 24, 36, and 60 months, with unplanned or interim visits as need for recurrent symptoms or complications. Follow-up visits included ABI measurements, Rutherford category assessment, and duplex ultrasound examination.