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
Patients with peripheral artery disease due to occlusive lesions, stenosis of ingraguinal arteries and restenosis after previous angioplasty with/without stent in that sector.
Cohort
Prospective
LUMINOR© Paclitaxel eluting balloon
DevicePatients will be treated with the Luminor paclitaxel eluting balloon
Primary Endpoint Efficacy measured by presence of primary patency of the target lesion based on ultrasound images
Primary Patency is defined as Freedom from Clinically-Driven Target Lesion Revascularization and from Binary Restenosis.
Overall Medical Safety
Combination assessment of freedom from all-cause peri-procedural (≤30 day) death and freedom at 3 years from the following: index limb amputation (above or below the ankle), and all-cause mortality (with a detailed analysis of cardiovascular (CV) and non-CV deaths). Success is defined as freedom from all specified events; failure is defined as one or more specified events occurrences.
Secondary Endpoint Medical Safety: Major vascular complications
Major vascular complications will be counted: * Haematoma at access site \>5 cm * False aneurysm * AV fistula * Retroperitoneal bleeding * Peripheral ischemia/nerve injury * Any transfusion required will be reported as a vascular complication unless clinical indication clearly other than catheterization complication * Vascular surgical repair
Secondary Endpoint Medical Safety: Composite Safety
Combination assessment of freedom from all-cause death and freedom from the following: index limb amputation (above or below the ankle = major or minor amputation) and index limb re-intervention. Success is freedom from all specified events; failure is occurrence of one or more specified events.
Secondary Endpoint Medical Safety: All-cause death
Death by any cause will be counted and stratified between CV and non-CV deaths. Cause of death will be analyzed to search for any specific increase of a death's subtype.
Secondary Endpoint Medical Safety: Major amputation at target limb
Amputations above the ankle of the target leg will be counted. Optional histologic examination of fixed muscle segments in 10% neutral-buffered formalin could be performed in the Inserm unit 1034, Pessac, France to search for paclitaxel microparticle deposits, fibrinoid necrosis artery wall injury, inflammation, thrombus, hemorrhage, and fibrosis. Adjacent nonfixed samples of similar distal tissues, flash-frozen in liquid nitrogen, and retained at -80°C will be used for bioanalysis of paclitaxel levels by modified liquid chromatography/tandem mass spectroscopy.
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