A Study Evaluating the Endovascular Treatment of Subjects with Stenotic or Restenotic Lesions of the Common Femoral Artery with the Supera Vascular Mimetic Implant Compared to Surgical Common Femoral Artery Endarterectomy

Inclusion Criteria:

• Patient is ≥18 years old

• Patient presenting a score from 2 to 4 following Rutherford classification

• Patient is willing to comply with specified follow-up evaluations at the specifiedtimes

• Patient understands the nature of the procedure and provides written informedconsent, prior to enrolment in the study

• Patient has a life expectancy of at least 12 months

• Prior to enrolment, the guidewire has crossed the target lesion in the endovasculararm. In the surgical arm, the endarterectomy needs to be performed with primarysuture or patch implantation

• De novo stenotic or restenotic (post-PTA) lesions (<100%) located in the commonfemoral artery, suitable for both endovascular therapy and endarterectomy

• Target lesion is located within the native CFA: localized between 1cm proximal tothe origin of the circumflex iliac artery and the proximal (2cm) superficial femoralartery and deep femoral artery (2cm) (Azéma type 2 and 3 lesions)

• There is angiographic evidence of a patent deep femoral artery and/or superficialfemoral artery

• The target lesion has angiographic evidence of >50% stenosis. Occlusions are notallowed.

Exclusion Criteria:

• Presence of another stent in the target vessel that was placed during a previousprocedure

• Previous open surgery in the ipsilateral groin

• Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics

• Patients who exhibit persistent acute intraluminal thrombus at the target lesionsite

• Patients with known hypersensitivity to nickel-titanium and heparin, including thosepatients who have had a previous incidence of heparin-induced thrombocytopenia (HIT)type II

• Known allergy to contrast media that cannot be adequately pre-medicated prior tostudy procedure

• Patients with uncorrected bleeding disorders

• Female patients with child bearing potential not taking adequate contraceptives orcurrently breastfeeding

• Ipsilateral inflow (aorto-iliac) artery treatment before target lesion treatmentwith a residual stenosis >30%

• Use of thrombectomy, atherectomy or laser device during procedure

• Any patient considered to be hemodynamically unstable at onset of procedure

• Severe medical comorbidities (untreated coronary artery disease/congestive heartfailure, severe chronic obstructive pulmonary disease, metastatic malignancy,dementia, etc.) or other medical condition that would prelude compliance with thestudy protocol or 1-year life expectancy

• Major distal amputation (above the ankle) in the study limb or non-study limb

• Target lesion involves an (pseudo-)aneurysm or is adjacent to an (pseudo-)aneurysm (within 5mm)

• Iliac inflow disease requiring treatment, unless the iliac artery disease issuccessfully treated first during the index procedure. Success is defined as ≤30%residual diameter stenosis without death or major complications

• Presence of an aortic, iliac or femoral artificial graft

• Occlusion in the target lesion

• Presence of an interposition graft with/without profunda reimplantation