STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)

Cohort 1: General Inclusion Criteria:

• Has symptomatic leg ischemia, requiring treatment of the SFA and/or popliteal artery.
• Has a Rutherford Clinical Category of 2 - 4. Note: Rutherford Clinical Category 2 subjects should be entered into the study if conservative treatment has been unsuccessful.
• Is ≥18 years old.
• Has life expectancy >1 year.
• Is able and willing to provide written informed consent prior to study specific procedures.
• Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen.

Cohort 1: Angiographic Inclusion Criteria:

• Has evidence at the target lesion(s) of clinically and hemodynamically significant de novo stenosis or restenosis, or occlusion, in the SFA (1 cm distal to the ostium of the profunda) and/or popliteal artery (proximal to the popliteal trifurcation), confirmed by angiography.
• Has target limb with at least one patent ( 2 cm from any stent if the target vessel was previously stented.
• Has a reference vessel diameter of 4 - 6 mm by visual estimate.
• Has a successful exchangeable guidewire crossing of the lesion(s).

Cohort 1: General Exclusion Criteria:

• A female who is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing; or a male intending to father children during the study.
• Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
• Is currently participating in another investigational device or drug study that would interfere with study endpoints.
• Has history of hemorrhagic stroke within 3 months.
• Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure.
• Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
• Has had a previous peripheral bypass affecting the target limb.
• Has unstable angina pectoris, myocardial infarction, liver failure, renal failure or chronic kidney disease (dialysis dependent, or serum creatinine ≥2.5 mg/dL) within 30 days of the index procedure.

Cohort 1: Angiographic Exclusion Criteria:

• Has significant stenosis (≥50%) or occlusion of inflow tract that is not successfully revascularized ( 1 year.
• Is able and willing to provide written informed consent prior to study specific procedures.
• Is willing and capable of complying with the required follow-up visits, testing schedule and medication regimen.
• History of previous femoropopliteal nitinol stenting which is suspect for in-stent restenosis.
• The patient has a resting ankle-brachial index (ABI) 1.2) must have a toe-brachial index (TBI) 2 cm from any stent if the target vessel was previously stented.
• Has a reference vessel diameter of 4 - 6 mm by visual estimate.
• Has a successful exchangeable guidewire crossing of the lesion(s).

Cohort 2: General Exclusion Criteria:

• A female who is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing; or a male intending to father children during the study.
• Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
• Is currently participating in another investigational device or drug study that would interfere with study endpoints.
• Has history of hemorrhagic stroke within 3 months including those within 50% that is not successfully treated prior to index procedure (e.g. complication requiring additional treatment) or with final residual stenosis >30% documented by angiography. Drug eluting stent (DES) and drug coated balloon (DCB) will not