Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

Inclusion Criteria: * Peripheral artery disease * Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions * Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5 * Planed peripheral intervention TASC A-D * Subject must be between 18 and 85 years old * Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation * Vessel diameter ≥4.0 mm and ≤7.0 mm * Willing to comply with the specified follow-up evaluation * Written informed consent prior to any study procedures * Pretreatment with an adequately sized balloon Exclusion Criteria: * Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement * Instent-Restenosis * Thrombolysis within 72 hours prior to the index procedure * Aneurysm formations in the femoral artery or popliteal artery * Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy * Unstable angina pectoris at the time of the enrollment * Recent myocardial infarction or stroke \< 30 days prior to the index procedure * Life expectancy less than 12 months