BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries

Inclusion criteria

• Subject has provided written informed consent.
• Subject is willing and able to comply with follow-up evaluations.
• Subject is ≥ 18 years old.
• Single or sequential de novo or restenotic lesions (stenosis ≥ 70% diameter reduction or occlusion) in the infrapopliteal arteries ≥ 30 mm. Lesions should not extend beyond the ankle joint.
• A maximum of 2 different vessels can be treated: successful wire crossing is required for the first target vessel before randomization occurs.
• Subject with PAD or critical limb ischemia according to the current guidelines in need for urgent revascularization to relieve symptoms and improve walking capacity.
• Reference Vessel Diameter (RVD) 2 - 4 mm, based on visual estimation.
• Inflow free from flow-limiting lesion confirmed by angiography. Patients with flow-limiting inflow lesions (> 50% stenosis) can be included if lesion(s) have been treated successfully before the index procedure, with a maximum residual stenosis of 30% per visual assessment.
• At least one non-occluded crural vessel with angiographically documented run-off to the foot.
• Successful wire crossing of the lesion.

Exclusion criteria

• 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 (DEB or DES not allowed for the treatment of inflow lesions).
• Infrapopliteal lesions extending beyond the ankle joint and involving crural vessels.
• Acute thrombus in the target vessel (eg complication of inflow lesion treatment) documented by angiogram, if not treated successfully prior to enrolment).
• Planned major amputation above the ankle of target limb, or any other planned major surgery within 30 days post-procedure.
• Previous bypass surgery of target vessel.
• Previously implanted stent in target lesion.
• Haemorrhagic diathesis or coagulopathy or other disorders such as gastrointestinal ulcerations or cerebral disorders that would restrict prescription of dual anti-platelet therapy.
• Subject with hepatic failure, deep vein thrombosis, thrombophlebitis, systemic lupus erythematous or subject is on immunosuppressant therapy.
• Subject with acute MI ≤ 3 months.
• Renal failure with a creatinine of ≥ 2,5 mg/dl, except patients currently on regular dialysis.
• Phenprocoumon intake, except for patients who are treated for Arterial Fibrillation. For these patients Phenprocoumon treatment can be interrupted and re-started after treatment with Dual Antiplatelet Therapy for 4 weeks post procedure.
• Known allergy to contrast media used for angiography that cannot be controlled by pre-medication with steroids and/or antihistaminica.
• Allergy, intolerance or hypersensitivity to Paclitaxel or related compounds and/or to the delivery matrix n-Butyryl tri-n-hexyl citrate(BTHC).
• Co- morbid conditions limiting life expectancy ≤ 1 year.
• Patients that are under active treatment for cancer; Patients, who have been successfully treated for cancer in the past, can be included.
• Subject is participating in another clinical device trial where the primary endpoint has not yet been reached.
• Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.