A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients

Key Inclusion Criteria: * Rutherford Category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest). * The target lesion(s) has evidence of narrowing or blockage and can be stented. * The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm. * The target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm Key Exclusion Criteria: * The subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum) * The subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines) * The subject has a history of bleeding disorders (diatheses or coagulopathy). * The subject has kidney failure or is having dialysis treatment. * The subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots. * Subject has Acute Limb Ischemia (a sudden loss of blood flow to the limb). * Subject has a history of bypass surgery on the study vessel. * Subject has a history of heart attack or stroke within 6 months of study procedure. * The subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response). * The subject is diagnosed with a severe infection (septicemia). * Principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft. * The subject with a stent previously implanted into the target vessel. * Subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days. * Pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial. * The subject is participating in an investigational drug or another investigational device study. * Subject has a large amount of blood clot next to the study lesion.