BIOLUX P-I First in Man Study

Inclusion criteria

• Age ≥ 50 years,
• Informed consent signed by patient prior to randomization
• Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
• Rutherford Class 2 - 5 in the target limb
• Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
• Inflow free from flow-limiting lesion (< 50% stenosis) confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion has been treated successfully before the index procedure
• At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
• Successful wire crossing of the lesion
• Willingness to comply with all specified follow-up evaluations
• Male or negative pregnancy test of women in childbearing age

Exclusion criteria

• Co-morbid conditions limiting life expectancy ≤ 1 year
• Patient currently participating in another clinical trial
• Lesions which are untreatable with PTA or other interventional techniques
• The target stenosis is located distal to a stenosis ≥ 50% that cannot be pre-treated because the drug coating could get lost during crossing the proximal lesion
• Thrombus in the target vessel, documented by angiography
• Target lesion is severely calcified, documented by angiography
• Prior bypass surgery of target vessel
• Previously implanted stent in the target lesion
• Treatment of bifurcation required
• Planned amputation of the target limb
• Flow-limiting (> 50% DS) Inflow lesion proximal to target lesion, left untreated
• Failure to obtain <30% residual stenosis in a pre-existing haemodynamically significant (>50% DS) inflow lesion in the ipsilateral iliac or proximal SFA. (DEB or DES not allowed for the treatment of inflow lesion)
• Additional hemodynamically relevant proximal and distal lesions with stenosis ≥ 50 %, except iliac arteries, are excluded. Iliac artery lesion treatments have to be successful with a residual stenosis ≤ 30 %
• Haemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy
• Phenprocoumon intake
• Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
• Known allergy to contrast media that cannot be adequately controlled with pre-medication
• Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)