BIOLUX P-I First in Man Study

A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).

A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.

Inclusion Criteria:

1. Age ≥ 50 years,
2. Informed consent signed by patient prior to randomization
3. Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the femoropopliteal arteries ≥ 30 mm and ≤ 200 mm long
4. Rutherford Class 2 - 5 in the target limb
5. Reference Vessel Diameter (RVD) 3 - 7 mm, based on visual estimation
6. 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
7. At least one non-occluded crural vessel (eg without significant stenosis) with angiographically documented run-off to the foot
8. Successful wire crossing of the lesion
9. Willingness to comply with all specified follow-up evaluations
10. Male or negative pregnancy test of women in childbearing age

Exclusion Criteria:

1. Co-morbid conditions limiting life expectancy ≤ 1 year
2. Patient currently participating in another clinical trial
3. Lesions which are untreatable with PTA or other interventional techniques
4. 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
5. Thrombus in the target vessel, documented by angiography
6. Target lesion is severely calcified, documented by angiography
7. Prior bypass surgery of target vessel
8. Previously implanted stent in the target lesion
9. Treatment of bifurcation required
10. Planned amputation of the target limb
11. Flow-limiting (> 50% DS) Inflow lesion proximal to target lesion, left untreated
12. 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)
13. 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 %
14. 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
15. Phenprocoumon intake
16. Impaired renal function (creatinine ≥ 2.0 - 2.5 mg/dl), according to investigator assessment
17. Known allergy to contrast media that cannot be adequately controlled with pre-medication
18. Allergy, intolerance or hypersensitivity to Paclitaxel structurally or related compounds and/or to the delivery matrix n-Butyryl tri-nhexyl citrate (BTHC)