Methods
In this prospective, two-center randomized trial of PTA vs. CRYO of infrainguinal vessels, the primary endpoint of TLR was evaluated at 6 months. Secondary endpoints included the rate of bailout stenting because of suboptimal acute angiographic results (defined as a residual narrowing of ≥30% or type C or higher dissection) and target vessel revascularization (TVR). Major Adverse events including death and amputations were recorded. A two-sample t test was used to compare the two groups on the continuous variables. For categorical variables, cross-tabular analysis was conducted with nonparametric tests ( χ 2 and Fisher’s Exact Test) used to test for significant differences.