Study Design
above-the-knee, COPD, CHF
CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, CONGESTIVE HEART FAILURE, CHF, CORONARY ARTERY DISEASE
The study design has been previously described [The study designers aimed to ensure consistent treatment in the control arm. To achieve this, they selected one type of bypass graft based on existing literature that compared prosthetic to venous grafts for above-the-knee femoropopliteal bypass procedures [Table Inclusion and Exclusion CriteriaCAD, coronary artery disease; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; ePTFE, expanded polytetrafluoroethylene; SFA, superficial femoral arteryTo determine if the effect of treatment with the ZILVER PTX paclitaxel-eluting stent was not inferior to the effect of treatment with surgical bypass, a sample size of 220 patients was calculated, assuming the 1-year primary patency rates for the bypass arm and the ZILVER PTX arm were 70.00% and 80.00%, respectively. The null hypothesis was that the primary patency rate for the ZILVER PTX arm was 6.00% lower than the primary patency rate for the bypass arm; the study had a power of 86.50% to reject the null hypothesis.