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.