Clinical Research Directory

Inclusion Criteria: 1. Lesion(s) in the infrainguinal arteries 2. Reference Vessel Diameter 2-7mm 3. De novo stenotic, restenotic post POBA (the phenomenon where atherosclerotic plaques form in the treated arteries after balloon angioplasty), or occlusive lesion(s) 4. Target lesion must have angiographic evidence of ≥70% stenosis 5. Lesion length ≥ 3cm 6. Successful crossing of the target lesion with the guide wire 7. Successful predilatation, defined as residual stenosis \<50% without flow limiting dissection grade D, E or F (Modified Fujihara classification) 8. Rutherford Class 2-5 9. Study participant is able to provide consent and has signed and dated the informed consent form Exclusion Criteria: 1. Life expectancy ≤ 1 year 2. Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet. 3. Study participant is pregnant or planning to become pregnant during the course of the study. 4. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion). 5. Prior bypass surgery of target vessel 6. In-stent restenosis 7. Planned major amputation of the target limb 8. Thrombus in the target vessel 9. Known allergy to contrast media that cannot be adequately controlled with premedication