ASSESS Study: Evaluation of ABSOLUTE™ Stent System for Occluded Arteries

Inclusion Criteria:

• De novo lesion of the superficial femoral artery (SFA) or proximal popliteal artery within the following parameters:

  • 10 mm distal to the origin of the profunda femoris (= 10 mm from the femoral bifurcation in the SFA) and
  • 20 mm from the proximal margin of the intercondylar fossa.
• Patients must have symptomatic leg ischemia, requiring treatment of the superficial femoral/proximal popliteal vessel
• Target vessel reference diameter visually estimated to be > 4.0 mm and < 7.0 mm
• Target lesion length visually estimated to be > 40 mm and < 200 mm
• If the patient has a contralateral SFA or contralateral proximal popliteal lesion, this lesion can be treated as a non-target lesion. The time and way of treatment of the non-target lesion will be left up to the discretion of the investigator
• At least one-vessel run-off to the foot confirmed by baseline angiography
• Patent common iliac artery, common femoral artery and profunda confirmed by baseline angiography. The patent common iliac artery can be obtained during the index procedure by a successful treatment prior to the treatment of the target lesion. Successful treatment being defined as attainment of final residual diameter stenosis of < 30% without death, stroke, bleeding requiring > 2 units transfusion, or any other complication which was device or procedure related.
• Patient is acceptable candidate for femoral-popliteal artery bypass surgery

Exclusion Criteria:

• Previous ipsilateral femoro-popliteal or femoro-tibial surgery
• Presence of a stent in the target vessel
• Prescheduled staged procedures of multiple lesions within the ipsilateral iliac or ipsilateral popliteal arteries within 30 days after the index procedure
• Co-existing aneurysmal disease of the abdominal aorta or iliac or popliteal arteries
• Acute thrombophlebitis or deep vein thrombus
• Any immunosuppressive disorders, groin infection, or acute systemic infection due to any cause or any viral or bacterial infection
• Significant gastrointestinal (GI) bleed within the past month that would contraindicate the use of anti-platelet therapy
• Hemodynamic instability
• Target lesion is restenotic from previous intervention