Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries

A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries

To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA

The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm < RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB).

The primary safety and efficacy endpoint assessments are performed at 12 months. Clinical follow-up continues through a minimum of 2 years and telephone follow-up through a minimum of 3 years.

Inclusion Criteria:

Clinical Criteria

1. ≥ 18 years of age;

2. Rutherford Clinical Category 2-4;

3. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).

   Angiographic Criteria

4. Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;

5. TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;

6. de novo lesion(s) or non-stented restenotic lesion(s) > 90 days from prior angioplasty procedure;

7. Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;

8. Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;

9. Target vessel diameter between ≥ 4 and ≤ 7 mm and able to be treated with available device size matrix;

10. A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac inflow artery lesions); NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication.

11. Successful wire crossing and pre-dilatation of the target lesion; NOTE: Use of crossing devices allowed if necessary NOTE: Bare nitinol stenting of short segments (length minimized to the mechanical defect) is required after pre-dilatation to resolve flow-limiting dissections or if deemed clinically necessary.

12. At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography that has not previously been revascularized (treatment of outflow disease is NOT permitted during the index procedure);

13. No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment.

Exclusion Criteria:

1. 1. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
2. Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
3. Life expectancy of < 1year;
4. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
5. History of stroke within 3 months;
6. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
7. Prior vascular surgery of the index limb, with the exception of endarterectomy or remote common femoral patch angioplasty, separated by at least 1 cm from the target lesion;
8. Target lesion involves a previously placed stent
9. Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication;
10. No normal proximal artery segment in which duplex flow velocity can be measured;
11. Significant inflow disease. Successful treatment of inflow iliac disease allowed prior to target lesion treatment;
12. Unsuccessful crossing; NOTE: crossing devices allowed
13. Known inadequate distal outflow (> 50% stenosis of distal popliteal or all three tibial vessels), or planned future treatment of vascular disease distal to the target lesion;
14. Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel;
15. Intended use of laser, atherectomy or cryoplasty during the index procedure.