Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries. The long-term success of bare balloon PTA in the fem-oropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter.~The rationale of this study is based on the hypothesis that the usage of the Sirolimus-coated Magic Touch Sirolimus DCB is at least equal (non-inferior) with regards to efficacy and safety in comparison with a clinically well-established PTX coated balloon.~The objective of this prospective, randomized, multi-center, post-market study is to compare the Magic Touch Sirolimus DCB with Paclitaxel-coated DCB for treatment of high grade ste-notic or occluded lesions in SFA and / or P1 segment of the popliteal artery (PA) in PAD pa-tients.
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial.~The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.