Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

Inclusion criteria

Clinical Inclusion:

• Must be at least 18 years of age.
• Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site.
• Symptomatic patient as evidence by IC or CLI.
• Patient has failed maximized medical treatment and exercise program.
• Patient has a resting ABI < 0.9 or an abnormal exercise ABI if resting ABI is normal.Patient with non-compressible arteries (ABI > 1.2) must have a TBI < 0.8.
• Patient has a de novo or restenotic lesion(s) with > 50% stenosis documented angiographically.
• Patient agrees to return for all required clinical contacts following study enrollment.
• Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure.

Anatomical Inclusion:

• Patient with any SFA lesion
• At least one tibial vessel runoff with < 50% stenosis
• Lesion starts start at least 1 cm distal to the deep femoral artery
• Lesion end at least 3 cm above the knee joint
• Target vessel reference diameter is > 3 mm & < 6.5 mm

Exclusion criteria

Clinical exclusion:

• Known allergic reaction to anesthesia not able to overcome by medication.
• Known allergic reaction to contrast not able to overcome by medication.
• Known history of intolerance to study medicating including ASA, clopidogrel, or ticlopidine.
• Bleeding disorder or refuses blood transfusion.
• Prior stenting or bypass of SFA (prior PTA is not an exclusion criteria)
• Unstable angina, recent MI within a month
• Malignancy or other condition limiting life expectancy to < 5 years.
• Renal insufficiency (serum Cr > 2.0)
• Patient has any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe (e.g., morbid obesity).

Anatomic Exclusion:

• Lesion < 1 cm from origin of DFA
• Lesion < 3 cm from the knee joint
• Chronic total occlusion of SFA > 20cm.
• Chronic total occlusion of CFA.
• Proximal trifurcation occlusions.