Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease

"Procedure can be conducted via either contralateral or antegrade approach. After a successful target lesion crossing, predilate the lesion using either plain old balloon angioplasty (POBA) or (if necessary) any available specialty balloon. The inflated diameter of the balloon should approximate the diameter of the vessel just distal to the lesion. Proper vessel preparation should achieve diameter of 1:1 to healthy vessel (with ≤20% residual stenosis, as per operator's assessment). Adjunctive debulking devices are prohibited.~Final stent selection should be confirmed after a proper vessel preparation, considering the reference vessel diameter (RVD) for the optimal 1:1 stent-to-vessel sizing. The implanted dual layer length would encompass the entire lesion with the micromesh, covering it from healthy to healthy tissue. Post-dilatation of the stent for more optimal placement may be done at operator's discretion, using standard angioplasty with uncoated balloon."