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

Exclusion Criteria

• •1. 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.
• •2. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• •3. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
• •4. Is currently participating in another investigational device or drug study that would interfere with study endpoints.
• •5. Has history of hemorrhagic stroke within 3 months.
• •6. Has surgical or endovascular procedure of the target limb within 14 days prior to the index procedure.
• •7. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
• •8. Has had a previous peripheral bypass affecting the target limb.
• •9. 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.
• •1. Has significant stenosis (≥50%) or occlusion of inflow tract that is not successfully revascularized (\<30% residual stenosis without death or major vascular complication) prior to treatment of the target lesion(s). Only treatment of target lesion(s) is acceptable after successful treatment of inflow iliac artery lesion(s).
• •2. Has an acute or sub-acute intraluminal thrombus within the target vessel.
• •3. Has in-stent restenosis or restenosis of the target lesion following previous treatment with a drug-coated balloon.
• •4. Has an aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.
• •5. Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment.
• •6. Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured.
• •7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy).
• •8. Has severe calcification that precludes adequate PTA treatment.
• •1. 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.
• •2. Has significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
• •3. Has known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
• •4. Is currently participating in another investigational device or drug study that would interfere with study endpoints.
• •5. Has history of hemorrhagic stroke within 3 months including those within \<60 days with an unresolved walking impairment.
• •6. Has surgical or endovascular procedure of the target limb within 3 months prior to the index procedure.
• •7. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
• •8. Has had a previous peripheral bypass affecting the target limb.
• •9. Has unstable angina pectoris, myocardial infarction within 60 days, liver failure, renal failure or chronic kidney disease (dialysis dependent, or serum creatinine ≥2.5 mg/dL) within 30 days of the index procedure.
• •10. History of previous femoropopliteal stenting in the target lesion with drug eluting stents or covered stents (endografts).
• •1. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis
• •≥50% diameter stenosis (DS) that is not successfully treated prior to index procedure (e.g. where a perforation occurred requiring a covered stent) or with final residual stenosis ≥ 30% documented by angiography.
• •2. Identification of any lesion of the native vessel (excludes ISR) above the target stent in the femoropopliteal segment \>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 be allowed. The lesion length must be treatable with a single stent (if required). The lesion must not be contiguous with the target lesion; at least 2 cm of normal appearing vessel between the lesion and target lesion/ target stent or between deployed stent (if required) and the target lesion/ target stent.
• •3. Has an acute or sub-acute intraluminal thrombus within the target vessel.
• •4. Has an aneurysm (at least twice the reference vessel diameter) located in the target vessel, abdominal aorta, iliac, or popliteal arteries.
• •5. Has perforation, dissection or other injury of the access or target vessel requiring stenting or surgical intervention prior to enrollment.
• •6. Has no normal arterial segment proximal to the target lesion in which duplex ultrasound velocity ratios can be measured.
• •7. Requires use of adjunctive therapies (i.e., laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy).
• •8. Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.