Combination assessment of freedom from all-cause death and freedom from the following: index limb amputation (above or below the ankle = major or minor amputation) and index limb re-intervention. Success is freedom from all specified events; failure is occurrence of one or more specified events.

Death by any cause will be counted and stratified between CV and non-CV deaths. Cause of death will be analyzed to search for any specific increase of a death's subtype.

Amputations above the ankle of the target leg will be counted. Optional histologic examination of fixed muscle segments in 10% neutral-buffered formalin could be performed in the Inserm unit 1034, Pessac, France to search for paclitaxel microparticle deposits, fibrinoid necrosis artery wall injury, inflammation, thrombus, hemorrhage, and fibrosis. Adjacent nonfixed samples of similar distal tissues, flash-frozen in liquid nitrogen, and retained at -80°C will be used for bioanalysis of paclitaxel levels by modified liquid chromatography/tandem mass spectroscopy.

Amputations below the ankle of the target leg will be counted.

Repeat intervention at the target vessel will be counted.

Repeat intervention at the target leg will be counted.

Device success is defined as, a per device basis, the achievement of successful delivery and deployment of the study device(s) as intended at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the study system. If a device is inserted into the subject but not used due to user error (e.g. inappropriate balloon length or transit time too long), this device will not be included in the device success assessment.

Technical Success of the balloon procedure is defined as successful access and deployment of the device and visual estimate of ≤ 30% diameter residual stenosis during the index procedure.

Attainment of ≤ 30% residual stenosis in the treatment area without major adverse events (defined as occurrence of death, major amputation of the target limb, target vessel or distal revascularization) during the index procedure and through the hospital stay.

Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis. Binary restenosis is adjudicated by the validated center based on threshold Doppler PSVR ≥ 2.5 (together with waveform analysis & color mosaic appearance) or based on angiographic ≥ 50% diameter stenosis (if angiography is performed although not required per protocol).

Secondary Patency of the target lesion is defined as the absence of binary restenosis as adjudicated by the validated center, independent of whether or not patency is re-established via an endovascular procedure.

Revascularization of the target lesion with evidence of diameter stenosis >50% determined by duplex ultrasound or angiography and new distal ischemic signs (worsening ABI or worsening Rutherford Category associated with the target limb or due to clinical symptoms).

A repeat revascularization procedure (percutaneous or surgical) of the original target lesion site.

Patients are enrolled with a Rutherford grade of 2-5 for their target leg. The Rutherford scale is an indicator for the severity of Peripheral Vascular Disease: 0 = no symptoms, 6 = functional foot is no longer salvageable (leading to foot amputation).

The ABI values will be recorded and compared to the baseline values. The ABI is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. A ratio of 0.9-1.3 is in the normal range. Lower ratios indicate bad blood perfusion of the leg.

The Walking Impairment Questionnaire values will be recorded and compared to the baseline values.

The EQ-5D Questionnaire values will be recorded and compared to the baseline values.