Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent

Formula™ 535 Iliac Balloon-Expandable Stent

Freedom from major adverse events

Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)

Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)

Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)

30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)

Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure)

Rate of functional status improvement based on walking impairment questionnaire

Rate of improvement in Rutherford Category (i.e., improvement above baseline)