The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY
The aim of this IIT is to determine the potential improvement and impact of the BioMimics 3D Stent System in the SFA on local vascular function.
• Peripheral artery disease
• Target lesions in the proximal (3 cm distal to the CFA-bifurcation) middle and distal SFA
• Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2,3,4
• Planed peripheral intervention TASC A-D
• Subject must be between 18 and 85 years old
• Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12 month angiographic evaluation
• Vessel diameter \>/= 4.0 mm and \</=7.0 mm
• Target lesion length \< 140 mm (segment to be stented)
• Willing to comply with the specified follow-up evaluation
• Written informed consent prior to any study procedures
• Pretreatment with an adequately sized ballon (1:1 ration to nonstenotic vessel diameter)
• usage of Biomimics stent as described in the IFU, especially regarding stent diameters and vessel size