A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

Exclusion Criteria

• •Patients will be excluded if ANY of the following conditions apply:
• •Breastfeeding or pregnant or planning on becoming pregnant or men intending to father children;
• •Life expectancy of \< 2 year;
• •Patient is currently participating in an investigational drug or other device study or previously enrolled in this study;
• •History of stroke within 3 months;
• •History of MI, thrombolysis or angina within 2 weeks of enrollment;
• •Renal failure or chronic kidney disease with MDRD GFR ≤30 ml/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis);
• •Diagnosed active systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure
• •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;
• •Inability to take required study medications or allergy to paclitaxel or paclitaxel related compounds or contrast that cannot be adequately managed with pre- and post-procedure medication;
• •The lesion is a post-DCB restenosis, or within or adjacent to an aneurysm; Ipsilateral retrograde access;
• •There is no normal proximal arterial segment in which duplex flow velocity can be measured;
• •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;
• •Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel;
• •Severe calcification that renders the lesion un-dilatable or failed pre-dilatation, defined by a residual stenosis \>50% or major flow limiting dissection;
• •Use of adjunctive treatment modalities (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, embolic protection device, etc.).