Treatment of SFA Lesions With 480 Biomedical STANZA™ Drug-Eluting Resorbable Scaffold (DRS) System

Exclusion Criteria

• •1. Previous vascular surgery/endovascular treatment of the target lesion.
• •2. Re-vascularization of target vessel within 30 days of study procedure.
• •3. Critical limb ischemia defined as Rutherford Becker Category 4-6.
• •4. Known coagulation disorders or intolerance or allergies to aspirin, clopidogrel or ticlopidine, heparin, any scaffold components, contrast agents which cannot be adequately pre-medicated.
• •5. Life expectancy ≤12 months.
• •6. Planned procedure that necessitates the discontinuation of antiplatelet medications used in conjunction with the investigational device within 3 months post-procedure.
• •7. Inability to walk due to orthopedic or other nonvascular complications.
• •8. Pregnancy or breast feeding or patient desires to become pregnant.
• •9. Non-atherosclerotic lesion (e.g. vasculitis).
• •10. Renal insufficiency (serum creatinine level \> 220 µmol/L or \> 2.5 mg/dl, or patient is on dialysis).
• •11. Patient has medical condition(s) which could affect study assessments or may adversely affect the safety and/or success of the study treatment.
• •12. Active systemic infection or lower limb infection of any nature.
• •13. White Blood Cells (WBC) ≤ 3,000 cells/mm3.
• •14. Myocardial infarction within 30 days prior to the study procedure.
• •15. Stroke within 90 days prior to the study procedure.
• •16. Uncontrolled atrial fibrillation.
• •17. Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
• •18. Prior use of paclitaxel-eluting products in the target limb less than 6 months prior to index procedure.
• •19. Patient has known unstable angina.
• •1. Target lesion treatment with a drug eluting balloon.
• •2. Target lesion treatment with atherectomy, laser, or cryoplasty (use of a cutting or scoring balloon is permitted prior to scaffold implantation only).
• •3. Suspicion for or evidence of subintimal passage of guidewire.
• •4. Severely calcified lesion(s).
• •5. Target lesion which, based on two angiographic orthogonal views, exhibit a persistent balloon deformity during pre-dilatation with a nominally sized balloon.
• •6. Target vessel (superficial femoral artery) has an angiographically significant (\> 50% diameter stenosis) lesion located distally or proximally to the target lesion.
• •7. Acute embolic complication following pre-dilatation.
• •8. Target vessel contains an acute thrombus.
• •9. Aneurysm in target vessel or co-existing clinically significant aneurysmal disease of the abdominal aorta, iliac or popliteal arteries.
• •10. Intervention in the infra-inguinal arteries outside of the target lesion.
• •11. Planned procedure within 30 days after the index procedure.
• •12. Positive pregnancy test for females of child bearing potential.