Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access

Exclusion Criteria

• •1. The patient has had/experienced any prior intervention/treatment to the target vessel within 90 days prior to enrollment (e.g., previously implanted graft in the aorta or target vessel; stroke; cryoplasty, laser or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, superficial femoral or popliteal artery).
• •2. Previously deployed stent at the site of the target lesion
• •3. The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel
• •4. Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting procedure
• •5. Use of mechanical devices on or thrombolysis of the target vessel within 72 hours prior to the index procedure without complete resolution of the thrombus
• •6. The patient is receiving any form of dialysis.
• •7. The patient is receiving any form of immunosuppressant therapy.
• •8. Planned amputation
• •9. Established vasospastic disease
• •10. Glomerular filtration rate (GFR) \< 30 mL/min within 7 days prior to the index procedure
• •11. The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.
• •12. Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index procedure
• •13. Bleeding diathesis
• •14. Known allergies or intolerance to antiplatelet, anticoagulant or thrombolytic medications including but not limited to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®) or heparin that cannot be medically managed.
• •15. Known allergy or intolerance to Nitinol (nickel titanium)
• •16. Known allergy to contrast agent that cannot be medically managed before treatment with steroids and/or antihistamines.
• •17. Known or suspected active infection at the time of the index procedure.
• •18. Patient is currently participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or is planning to participate in such a study prior to their completion of this study.
• •19. Patient has had a major surgical or interventional procedure unrelated to this study within 30 days prior to enrollment or is anticipated/planned to have such a procedure within 30 days after enrollment.
• •20. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
• •21. Noted perforation of the target vessel
• •22. Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) bifurcation
• •23. Cases of chronic total occlusion/in-stent restenosis/severe calcification in which there is pre-determined inability to treat the target lesion with a single stent, or procedures pre-determined to require stent-in-stent placement to obtain patency
• •24. Presence of thrombus prior to crossing the lesion
• •25. Successful PTA treatment of a target lesion in the SFA/PPA (defined as \< 50% stenosis after PTA treatment)