BioMimics 3D Stent Clinical Investigation: The Mimics Study

Exclusion Criteria

• •Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment (if not already post menopausal) or women who do not agree to use an adequate birth control method for up to 24 months after Device implantation
• •An uncontrolled infectious disease
• •A condition that inhibits radiographic visualisation of the arteries
• •Any condition that precludes safe access with PTA devices, such as: excessive common femoral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified
• •Known allergy to, or intolerance of, Nitinol
• •Known intolerance of aspirin and/or clopidogrel
• •Known hypersensitivity to contrast media which cannot be pre-treated
• •Participation in another device or drug study. Subject must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this study. The subject may only be enrolled in this study once
• •The subject is unable and/or unwilling to cooperate with study procedures or required follow-up visits
• •History of bleeding diatheses or coagulopathy or will refuse blood transfusions
• •Known impaired renal function, defined as creatinine \>2.5 mg/dl except subjects under chronic renal replacement therapy
• •Known platelet count \<80,000 cells/mm3 or \>700,000 cells/mm3
• •Known WBC of \<3,000 cells/mm3
• •The subject is unable to bend lower limbs (full knee flexion) and/or has a knee prosthesis
• •Previous treatment of the target lesion 6 months prior to enrollment; previous femoropopliteal bypass in the target vessel; previous stenting of the target lesion
• •Previous stenting of the SFA, popliteal and tibial arteries within the target limb
• •Target lesion located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
• •Target lesion requires treatment other than standard PTA prior to stent placement (i.e., no other devices or procedures such as cutting balloons and laser atherectomy are permitted to be used during the index procedure)
• •Lesions in contralateral SFA that require intervention during the index procedure, or within 30 days after the index procedure, unless both limbs are able to be and are included in the study
• •Multiple lesions in the target vessel that require stenting within 30 days after study procedure
• •Target lesion length is \> 10cm or the physician believes prior to stent placement that the lesion cannot be covered by one single stent
• •The target lesion is severely calcified