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 femoropopliteal 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 trial is based on the hypothesis that the usage of the MagicTouch drug-coated balloon (DCB) is at least equal (non-inferior) with regard to efficacy and safety in comparison with a clinically well-established paclitaxel drug-coated balloon (PTX DCB).
The objective of this prospective, randomized, multi-center trial is to compare the Magic Touch® DCB with PTX DCBs for treatment of high-grade stenotic or occluded lesions in supeficial femoral artery (SFA) and/or P1 segment of the popliteal artery in PAD patients.
Subject age ≥ 21 years
Subject has been informed of the nature of the trial, the duration of the trial, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.
Rutherford category 2-4 according to the investigator's subjective evaluation
Subject has de-novo or re-stenosed lesion with ≥ 70% stenosis documented angiographically, and no prior stent in the target lesion.
Failure of the guidewire to successfully cross the target lesion or subintimal target lesion.
Flow-limiting dissection after pre-dilatation and/or residual stenosis > 30% prior to randomization.
Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel).
Presence of fresh/organized thrombus in the target lesion.