The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.
≥ 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
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
iVascular S.L.U.
Lead sponsor