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

The study will enroll patients presenting with claudication or ischemic rest pain due to stenotic lesions in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful pre-dilatation, subjects determined by the investigator not to require stenting based on defined angiographic criteria will receive the BARD LTX DCB. .

Inclusion criteria

• Male or female ≥18 and < 85 years of age;
• Documented diagnosis of peripheral arterial disease (PAD) with Rutherford Classification stages 2-4;
• Patient is willing to provide informed consent and comply with the required - follow up visits, testing schedule and medication regimen;

Angiographic Criteria

• Single lesion or up to two focal lesions (not separated by >3 cm) (total vessel segment length ≤20 cm) in native superficial femoral and/or popliteal arteries;
• ≥70% diameter stenosis by visual estimate;
• Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
• De novo lesion(s) or non-stented restenotic lesion(s) >90 days from prior angioplasty procedure;
• Lesion is located at least 3 cm from any stent, if target vessel was previously stented;
• Target vessel diameter between ≥4 and ≤7 mm and able to be treated with available device size matrix;
• Successful, uncomplicated (without use of a crossing device) antegrade wire crossing of lesion;
• A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow iliac and/or common femoral artery lesions);
• No vascular interventions, surgical or interventional procedures within 2 weeks before and/or planned 30 days after the protocol treatment.

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.).