SuperB Trial: SUrgical Versus PERcutaneous Bypass

Inclusion criteria

• Age over 18 years
• Informed consent
• Novo stenosis, restenosis >50% or occlusion of the native SFA, all > 10cm in length
• Patent popliteal artery at the upper margin of the patella to the trifurcation
• Diameter native SFA and popliteal artery are 5.0-7.5 mm
• Indication for surgical bypass
• Distal run-off at least one crural artery without significant stenosis
• Ankle-brachial index (ABI) at rest < 0.8 in the study limb prior to procedure

Exclusion criteria

• Patient unsuitable for administration of contrast agent
• Pregnancy
• Dementia or altered mental status that would prohibit giving conscious informed consent
• Need for adjunctive major surgical or vascular procedures within one month
• Untreated flow-limiting aortoiliac occlusive disease
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
• Femoral or popliteal aneurysm of target vessel
• Non-arthrotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol
• Major distal amputation (above the transmetatarsal) in the study limb
• Any previously known coagulation disorder, including hypercoagulability
• Contraindication to anticoagulation or antiplatelet therapy
• Known allergies to stent/stent-graft components
• History of prior life-threatening reaction to contrast agent
• Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
• Planned surgical procedure or major amputation to occur after enrollment of the patient