First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease

Inclusion criteria

• Age ≥ 18 years and of age of legal consent.
• Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.80.
• A single superficial femoral artery lesion with >50% stenosis or total occlusion.
• Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≤ 150 mm.
• Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 5.0 mm by visual assessment.
• Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
• Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot.
• The target lesion(s) can be successfully crossed with a guide wire and dilated.
• The subject is eligible for standard surgical repair, if necessary.
• Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.

Exclusion criteria

• Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
• Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
• Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion either within the same procedure or at least 30 days prior to the index procedure.
• Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
• Presence of an ipsilateral arterial artificial graft.
• Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
• Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
• Required stent placement (in the target or any other lesion) via a retrograde approach.
• Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
• Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
• Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
• Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
• Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
• Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
• Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
• Overlapping stents are not allowed.
• Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
• Stroke within the previous 30 days of the index procedure.
• Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), PDLG, PLC, PDL, limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds) or contrast agent, that cannot be medically managed.
• Receiving dialysis or immunosuppressant therapy within the previous 30 days.
• Known or suspected active systemic infection at the time of the procedure.
• Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
• Platelet count <50,000/μL
• International normalized ratio (INR) > 1.5
• GFR <30 ml/min by Cockroft-Gault.
• Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.
• Planned use of a drug coated balloon (DCB) during the index procedure.
• Pregnant women or women of childbearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment.
• Subject is participating in any investigational study that has not yet reached its primary endpoint