SuperB Trial: SUrgical Versus PERcutaneous Bypass

• primary (and -assisted) patency [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
• Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]

• secondary patency [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
• complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
• clinical improvement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
• re-intervention [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
• target lesion revascularisation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.

• Experimental: heparin-bonded endoluminal fempop bypass
  heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass
  Intervention: Procedure: heparin-bonded ePTFE endoluminal fem-pop bypass
• Active Comparator: surgical femoro-popliteal bypass
  Surgical femoro-popliteal bypass.
  Intervention: Procedure: heparin-bonded ePTFE endoluminal fem-pop bypass

Inclusion Criteria:

• age over 18 years
• informed consent
• de 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