ULTRASCORE™ Focused Force PTA Balloon Angioplasty for CLI Patients With Below the Knee Vessel Disease

Inclusion Criteria:

1. Patients must be ≥ 18 years of age.
2. Patients are male or, if female, are either not of childbearing potential or must havea negative pregnancy test done within 7 days prior-index procedure and effectivecontraception must be used during participation in the Clinical Investigation.
3. Patients who are mentally and linguistically able to understand the aim of theClinical Investigation and to show sufficient compliance in following the ClinicalInvestigation Plan.
4. Patients must agree to return for all required post-index procedure follow-up visits.
5. Patients are able to verbally acknowledge an understanding of the associated risks,benefits, and treatment alternatives to therapeutic options of the ClinicalInvestigation. Patients, by providing their informed consent, agree to these risks andbenefits as stated in the patient informed consent document.
6. Rutherford Class 4-5
7. ≥70% stenosis of lower limb lesion by angio visual assessment
8. Target vessel(s) reconstitute(s) at or above the ankle with inline flow to at leastone patent pedal vessel (includes perforating peroneal branches to dorsalis pedis andplantar artery).
9. The target lesion must either be de-novo or re-stenotic (stenosis ≥ 70% or occlusionby visual estimate). If the target lesion is re-stenotic, the prior PTA must have beendone > 30 days prior-index procedure.
10. Treatment of multiple target lesions is allowed, as long as the composite targetlesion length is ≤ 30 cm
11. At least one target lesion that is ≥ 2cm in length

Exclusion Criteria:

1. Patients with a known hypersensitivity or contraindication to aspirin, heparin,clopidogrel, or other anticoagulant/anti-platelet therapies, Paclitaxel (or analogs)or sensitivity to contrast media that cannot be adequately premedicated.
2. Patients with any contraindications as mentioned in the Instructions for Use (IFU) ofthe Investigational Device.
3. Patients with a life expectancy, from the Investigator's opinion, of less than 2years.
4. Patients that are currently participating in other clinical investigations involvingany investigational drug or device that may potentially confound the results of theClinical Investigation, or that would limit the patient's compliance with thefollow-up requirements of the Clinical Investigation.
5. Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
6. Patients with a history of major disabling stroke within 3 months prior indexprocedure.
7. Patients with a presence or history of severe renal failure (Glomerular FiltrationRate (GFR) ≤ 25 ml/min).
8. Patients who have undergone prior vascular surgery of the index limb to treatatherosclerotic disease.
9. Patients with clinically significant aneurysmal disease of the iliac, femoral orpopliteal artery and patients with a history of clinically significant abdominalaortic aneurysm.
10. Target vessel(s) reconstitute(s) below the ankle with no inline flow to at least onepatent pedal vessel.
11. Subjects scheduled to undergo a planned major amputation