ILLUMENATE Pivotal Post-Approval Study (PAS)

Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E

Study subjects must fulfill the following clinical criteria:

• Symptomatic leg ischemia, requiring treatment of the superficial femoral artery (SFA) and/or popliteal artery.
• Greater than or equal to 18 years of age.
• Willing to provide written informed consent, and capable and willing to comply with all required follow-up evaluations within the defined follow-up visit windows.
• Will not undergo other planned vascular interventions within 14 days before and/or 30 days after the protocol treatment (successful treatment of ipsilateral and contralateral iliac permitted prior to enrollment).
• Life expectancy >1 year.
• Rutherford-Becker classification of 2, 3 or 4.

Study Subjects must fulfill the following angiographic criteria:

• De novo or restenotic lesion (except for in-stent restenotic lesion) >70% within the SFA and/or popliteal artery in a single limb.
• Single lesion which is ≥3 cm and ≤18cm in length (by visual estimation). NOTE: Tandem lesions can be treated. A tandem lesion is defined as two distinct lesions with 3 cm or less of healthy vessel separating the two diseased areas. The total cumulative length of the tandem lesions, including the healthy vessel, must not exceed 18 cm.
• Lesion is treatable by no more than two (2) study devices.
• Successful wire crossing of the lesion. The guidewire advancement should not be indicative of the presence of fresh thrombus in the lesion.
• Target reference vessel diameter is ≥4 mm and ≤6 mm (by visual estimation).
• Inflow artery is patent, free from significant lesion stenosis (≥50% stenosis is considered significant) as confirmed by angiography. Treatment of a target lesion is acceptable after successful treatment of inflow artery lesion(s). NOTE: Successful inflow artery treatment is defined as attainment of residual diameter stenosis 5 cm.
• Contraindication to dual anti-platelet therapy.
• Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
• Current participation in an investigational drug or another device study.
• History of hemorrhagic stroke within 3 months.
• 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).
• 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.
• Treatment of lesions in the contralateral limb with the CVI Paclitaxel-coated PTA Catheter.
• Use of the CVI Paclitaxel-coated PTA Catheter in other than a single treatment session.
• 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:

• Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure.
• No normal proximal arterial segment of the target vessel in which duplex ultrasound velocity ratios can be measured.
• Known inadequate distal outflow.
• Acute or sub-acute thrombus in the target vessel.
• Aneurysmal target vessel.
• Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy) during the index procedure in the target lesion or target vessel.
• 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).
• Presence of concentric calcification