LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)

Exclusion Criteria

• •Patients will be excluded if ANY of the following conditions apply:
• •1. Pregnant or planning on becoming pregnant or men intending to father children;
• •2. Life expectancy of \<5 years;
• •3. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in another clinical trial during the follow up period is not allowed.
• •4. History of hemorrhagic stroke within 3 months;
• •5. Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
• •6. History of MI, thrombolysis or angina within 2 weeks of enrollment;
• •7. Rutherford Class 0, 1, 5 or 6;
• •8. Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis);
• •9. Prior vascular surgery of the index limb, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;
• •10. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
• •11. Anticipated use of IIb/IIIa inhibitor prior to randomization;
• •12. Ipsilateral retrograde access;
• •13. Composite lesion length is \>15 cm or there is no normal proximal arterial segment in which duplex flow velocity can be measured;
• •14. Significant inflow disease. Successful treatment of inflow disease allowed prior to target lesion treatment;
• •15. Known inadequate distal outflow (\>50 % stenosis of distal popliteal and/or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
• •16. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
• •17. Severe calcification that renders the lesion un-dilatable;
• •18. Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).