Prospective Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral And/or Popliteal Arteries Using the FLEX Scoring Catheter Plus DCB

Inclusion Criteria: * Women of child-bearing potential must have a negative test within 7 days of the initial procedure * Patient or patient's legal representative has been informed of the nature of the study, agrees to participate and comply with all follow-up visits, and has signed the informed consent. * Patient is eligible for standard surgical repair in the target limb if necessary. * Patient has Rutherford Clinical Category estimated as 2-6. * A life expectancy \>1 year. Angiographic Inclusion Criteria: * Target lesion(s) is located within the SFA and/or the popliteal arteries. * Target lesion has \>70% stenosis by visual assessment. * The reference vessel diameter is between 4-6 mm. * One long or multiple serial lesions. * de novo or non-stented re-stenotic lesions. * At least one BTK artery patent to the ankle. * Successful treatment of iliac inflow stenosis to the target limb. Stenosis can be treated during the same procedure using standard angioplasty and/or stenting but atherectomy is excluded. The inflow lesion(s) must be treated first, before consideration of treatment of the target lesion. Subject can be enrolled if the treated inflow lesion(s) results in \<30% residual stenosis and no evidence of embolization or significant complications. Exclusion Criteria: * Rutherford Clinical Category 1. * Previously implanted ipsilateral femoral or popliteal stent. * Evidence of aneurysm or acute thrombus in the target vessel. * Patients with previous bypass surgery i…