Clinical Research Directory

Inclusion Criteria: * ≥ 18 years of age * Rutherford Clinical Category 2-5 * The subject is legally competent, has been informed of the nature, the scope, and the relevance of the study, voluntarily agrees to participation, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF) * Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery * TASC II Class A to D Lesions * de novo lesion(s), non-stented or stented restenotic lesion(s) * Proximal margin of target lesion(s) starts at the ostium of the superficial femoral artery, just below the common femoral bifurcation * Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk (P3) * A patent inflow artery free from significant lesion (≥ 50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of iliac or common femoral inflow artery lesions); Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without death or major vascular complication * Successful wire crossing and pre-dilatation (1min min, with under sizing of 1mm compared to ref diameter) of the target lesion; Use of crossing devices allowed if necessary. Use of laser or atherectomy is allowed if necessary, during the index procedure. Bailout stenting is allowed if necessary, after DEB use * At least one patent native outflow artery to the ankle, free from significant (≥ 50%) stenosis as confirmed by angiography (treatment of outflow disease is NOT permitted during the index procedure) Exclusion Criteria: * Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children * Patient is contraindicated to use Luminor Drug Eluting Balloon per the current Instructions For Use (IFU) * Life expectancy of \< 1year * Patient is currently participating in an investigational drug or other device study or previously enrolled in this study * Inability to take required study medications or allergy to contrast that cannot be adequately managed with pre- and post-procedure medication * Sudden symptom onset, acute vessel occlusion, or acute or sub-acute angiographically visible thrombus in target vessel