ILLUMENATE Pivotal Post-Approval Study (PAS)

Exclusion Criteria

• •Subject with any of the following clinical criteria should be excluded:
• •1. Females who are pregnant, lactating, or intend to become pregnant, or males who intend to father children during study participation.
• •2. Known aortic aneurysm(s) \> 5 cm.
• •3. Contraindication to dual anti-platelet therapy.
• •4. Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
• •5. Current participation in an investigational drug or another device study.
• •6. History of hemorrhagic stroke within 3 months.
• •7. Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
• •8. Prior endovascular treatment of target lesion by percutaneous transluminal angioplasty or any other means of previous endovascular treatment (e.g. stents/stent grafts, cutting balloon, scoring balloon, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices) within six months of the index procedure, or any previous placement of a bypass graft proximal to the target lesion.
• •9. Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
• •10. Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
• •11. Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure).
• •Subject with any of the following angiographic criteria should be excluded:
• •12. Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.
• •13. No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.
• •14. Known inadequate distal outflow.
• •15. Acute or sub-acute thrombus in the target vessel.
• •16. Aneurysmal target vessel.
• •17. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.
• •18. Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries which can be treated prior to enrollment).
• •19. Presence of concentric calcification that precludes PTA pre-dilation.
• •20. Prior stent placement in the target vessel.
• •21. Residual stenosis of greater than 70%, stent placement or flow-limiting (Grade D or greater) dissection following pre-dilation.