4-EVER : a Trial Investigating the Safety of 4F Endovascular Treatment of Infra-Inguinal Arterial Stenotic Disease

• Technical success [ Time Frame: procedure (day 0) ] [ Designated as safety issue: No ]
  Technical success, defined as the ability to cross and stent the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging.
• Puncture site complications [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  Number of puncture site complications in the absence of a closure device after intervention
• Primary patency [ Time Frame: 6- & 24-month follow-up ] [ Designated as safety issue: No ]
  Primary patency rate at 6- & 24-month follow-up, defined as freedom from >50% restenosis at 6 & 24 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention.
• Clinical success [ Time Frame: 6-, 12- & 24-month follow-up ] [ Designated as safety issue: No ]
  Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12- & 24-month follow-up of one class or more as compared to the pre-procedure
• Stent fracture rate at 12- & 24-month follow-up [ Time Frame: 12- & 24-month follow-up ] [ Designated as safety issue: No ]

  Stent fracture rate at 12- & 24-month follow-up (in patient who were treated with stentplacement), as determined according the following classification on x-ray:

  1. Class 0 : no strut factures
  2. Class I : single tine fracture
  3. Class II : multiple tine factures
  4. Class III : Stent fracture(s) with preserved alignment of the components
  5. Class IV : Stent fracture(s) with mal-alignment of the components
  6. Class V : Stent fracture(s) in a trans-axial spiral configuration

The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device.

The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).

• Peripheral Vascular Disease
• Claudication

Inclusion Criteria:

• De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment
• Patient presenting with a score from 2 to 4 according to the Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times
• Patient is >18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
• Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
• Patient is eligible for treatment with 4F compatible devices

Angiographic Inclusion Criteria:

• The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis.
• The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion
• Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
• Target vessel diameter visually estimated is =4 mm and =6.5 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 bypass surgery in the same limb
• Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
• Patients who exhibit persistent acute intraluminal thrombus at the target 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
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Life expectancy of less than 12 months
• Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
• Use of thrombectomy, atherectomy or laser devices during procedure
• Any planned surgical intervention/procedure 30 days after the study 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 reached the primary endpoint