Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System

Inclusion Criteria:

• Patient with claudication or ischemic rest pain(Rutherford Categories 2-4)
• The angiogram will need to have been performed confirming superficial femoral artery short segment occlusion(<5cm first two patients and <10cm there on) or high grade(>50%)stenosis
• Patient has a signed and dated informed consent
• Patient has a resting ABI <0.9 or an abnormal exercise ABI if resting ABI is normal. Patients with incompressible arteries (ABI >1.2) must have TBI <0.8
• Life expectancy greater than one year
• The ability to comply with protocol follow up requirements and required testing

• Angiographic lesion requirements assessed at time of procedure

  • Lesion of the superficial femoral artery with a short segment occlusion(<5cm first two patients and <10cm there on) or high grade (>50%) stenosis
  • Target lesion 1 cm below profunda/superficial femoral artery origin and 3cm above knee joint
  • Angiographic evidence of a minimum of at least one tibial with continuous artery runoff to the ankle that does not require intervention
  • Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel, and successful placement of 9 french(Fr) sheath

Exclusion Criteria:

• Untreated iliac artery in-flow limiting lesion
• Significant proximal common femoral or superficial femoral artery disease above or below target lesion
• Any previously treated superficial femoral artery lesion
• Any previous stenting or surgery in the target vessel
• Femoral or popliteal aneurysm
• Non-Atherosclerotic disease resulting in occlusion (e.g. embolism, vasculitis,etc)
• Serum creatinine >2.5 mg/dl
• Any previously known coagulation disorder, including hypercoagulability
• Severe medical co-morbidities or other medical condition (for example untreated coronary heart disease and congestive heart failure, severe chronic obstructive pulmonary disease, metastasis malignance, etc.)