Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Inclusion Criteria:

- Male or non-pregnant female ≥18 years of age;

- Rutherford Clinical Category 3, 4 & 5;

- Life expectancy ≥ 1 year;

- Significant stenosis (≥70%)

- A patent inflow artery;

- Target vessel(s) diameter between 2 and 4 mm;

- Target vessel(s) reconstitute(s) at or above the ankle

Exclusion Criteria:

- Pregnant or planning on becoming pregnant;

- History of stroke within 3 months;

- History of MI, thrombolysis or angina within 30 days of enrollment;

- Planned major amputation (of either leg)

- Prior major amputation if amputation occurred less than one year prior to enrollment
and if patient is not independently ambulating;

- GFR ≤ 30 ml/min per 1.73m2;

- Acute limb ischemia;

- In-stent restenosis of target lesion