Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries

Exclusion Criteria

• •1. Rutherford Classification 0, 1, 5 or 6
• •2. Is pregnant or refuses to use contraception through the duration of the study
• •3. Previous infrainguinal bypass graft in the target limb
• •4. Planned amputation on the target limb
• •5. Systemic infection or infection within the target limb and/or immunocompromised
• •6. Endovascular or surgical procedure (not including diagnostic procedures) on the target limb within 30 days prior to or within 30 days after the index procedure
• •7. Endovascular or surgical procedure (not including diagnostic procedures) on the non-target limb within 14 days prior to the index procedure or planned procedure within 30 days after the index procedure
• •8. Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
• •9. Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
• •10. Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
• •11. Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter
• •12. Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy
• •13. Myocardial infarction within 30 days prior to enrollment
• •14. History of stroke within 90 days prior to enrollment
• •15. Serum creatinine of \>2.5 mg/dL
• •16. Requires treatment of tibial or outflow vessels at the index procedure, which include the P2 and P3 segments of the popliteal artery and the tibioperoneal vessels
• •17. Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
• •18. Participating in another ongoing investigational clinical trial that has not completed its primary endpoint
• •19. Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments
• •20. Known hypersensitivity or allergy to contrast agents that cannot be medically managed
• •21. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved