Clinical Research Directory

Inclusion Criteria: * 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. * Target lesion length is ≥ 40mm and ≤ 200mm by visual estimate of the treating physician. * Multiple lesions with max. A 30mm healthy vessel segment between lesions can be considered, at the treating physician's discretion, as one lesion. Total lesion length should not exceed 200mm. * Reference vessel diameter (RVD) ≥ 4mm and ≤ 7 mm by visual estimation. * Patency of P2 and P3 segments of the popliteal artery and at least one (1) infra-popliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the femoropopliteal artery. * Patency of the ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis \> 30% may be treated during the index procedure to ensure sufficient inflow. * Staged Intervention of the contralateral limb is permitted at +/- 30 days. * A subject can only be enrolled and randomized once with only one target lesion in the MAGICAL SFA trial. Note that only the lesion in one limb can be treated as a target lesion for the index procedure. Exclusion Criteria: * 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. * Presence of aneurysm in the target vessel/s. * Prior vascular surgery (including atherectomy , bypass surgery) of the target limb. * Prior stent in the target lesion. * Stroke or heart attack within three months prior to enrollment. * Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure. * Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to the index procedure. * Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, and/or cryoplasty brachytherapy re- entry devices. * Enrolled in another investigational drug, device, or biologic trial where the primary end point is not yet achieved. * Life expectancy of less than one year in the investigator's opinion. * Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, sirolimus, paclitaxel, or contrast media that cannot be adequately pre- treated prior to index procedure. * Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy. * Receiving dialysis or immunosuppressant therapy . (A systemic corticosteroid therapy with expected maximum dosage of 5mg prednisolone or equivalent, per day, during the initial 9 months after procedure, is allowed.) * Subjects with severe (Stage 4) renal disease, defined as eGFR \< 30%. * Pregnant or lactating females . * History of major amputation in the target lesion limb.