A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Exclusion Criteria

• •1. Pre-existing autoimmune disease.
• •2. Pre-existing terminal illness with life expectancy of less than three (3) years.
• •3. Participation in another investigational device or therapeutic intervention trial within the past three (3) months.
• •4. Previous enrollment in this study.
• •5. Previous bypass surgery or stenting in the SFA or distally.
• •6. Scheduled for a staged procedure to treat lesions within the aorta or run-off after enrollment.
• •7. Co-existing aneurysmal disease of the aorta, iliac artery, SFA, or popliteal arteries requiring treatment.
• •8. Any inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion) that has not been treated prior to enrollment (Treatment of iliac arteries before SFA intervention is permitted, except for common femoral stenosis).
• •9. A recent (\< 6 week) history of clinically significant gastrointestinal bleeding, major surgery, myocardial infarction or untreated coagulopathy.
• •10. Known sensitivity or allergy to aspirin, radiographic contrast agents (that cannot be pre-treated adequately), nitinol, gold, or both heparin and bivalirudin.
• •11. Angiographic evidence of acute thrombus.
• •12. Sudden worsening of symptoms in the last 30 days.
• •14. Severe calcification or excessive tortuosity at target lesion.
• •15. Subjects unable to tolerate anticoagulant therapy or antiplatelet therapy.
• •16. Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required).
• •17. The target lesion(s) cannot be successfully crossed with a guide wire.\*
• •18. Lower extremity deep venous thrombosis in the study limb within the prior 30 days.
• •19. Chronic venous disease with active or recent (\< 30 day) skin ulceration.
• •20. Known or suspected active systemic infection.
• •21. Two (2) months previous history of non-hemorrhagic stroke and or history of hemorrhagic stroke.
• •22. Treatment that requires access via upper extremity, popliteal artery, or pedal artery.
• •23. Evidence of severe or uncontrolled systemic disease of any condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
• •24. Use of re-entry, ablative, or atherectomy devices to cross the lesion.\*