Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions (DUR-POP)

• Technical success [ Time Frame: procedure (day 0) ] [ Designated as safety issue: No ]
  Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging
• Primary patency rate at 6-, 12-month follow-up. [ Time Frame: 6-, 12-month follow-up ] [ Designated as safety issue: No ]
  Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.
• Clinical success [ Time Frame: 6-, 12-month follow-up ] [ Designated as safety issue: No ]
  Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
• tent fracture rate at 12-month follow-up [ Time Frame: 12-month follow-up ] [ Designated as safety issue: No ]
  Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)
• Serious adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.

This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.

Inclusion Criteria:

General Inclusion criteria

• De novo, restenotic or reoccluded lesion located in the popliteal artery, with or without superficial femoral artery involvement
• Patient presenting a score from 2 to 5 following Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is >18 years old
• Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Prior to enrollment, the guidewire has crossed target lesion
• Patient is eligible for treatment with the self-expanding nitinol EverFlex (ev3) stent

Angiographic Inclusion Criteria

• The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
• The target lesion, visually estimated, has a maximal length of 14 cm and can be categorized as either a type A or B lesions according the TASC II guidelines
• Target vessel diameter visually estimated is >3.5mm and <7.5 mm
• There is angiographic evidence of at least one-vessel-runoff to the foot

Exclusion Criteria:

• Presence of another stent in the target vessel that was placed during a previous procedure
• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
• Previous by-pass surgery in the same limb
• Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
• Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Patients with known hypersensitivity to nickel-titanium
• Patients with uncorrected bleeding disorders
• Aneurysm located at the level of the SFA and/or popliteal artery
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Life expectancy of less than twelve months
• Ipsilateral iliac treatment before the target lesion procedure with a residual stenosis > 30% or ipsilateral iliac treatment conducted after the target lesion procedure
• Use of thrombectomy, artherectomy or laser devices during procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.