Stent or no stent? new study tests best approach for leg artery disease

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject age ≥ 18 2. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing. 3. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion. 4. Rutherford Becker Classification 2-4 5. Both treatment options seem feasible at the operator's discretion 6. Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible. 7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation. 8. Patency of at least one (1) infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery. The inflow artery(ies) cannot be treated using a drug eluting stent or drug coated balloon 9. A guidewire has successfully traversed the target treatment segment. Exclusion Criteria: 1. Failure to successfully cross the target lesion 2. Angiographic evidence of severe calcification that makes a stent-avoiding approach not feasible at the operator's discretion. 3. Femoropopliteal lesions classified as TASC II Typ A (single stenosis \>=10cm and single occlusion \>=5cm) 4. Presence of fresh thrombus in the lesion. 5. Presence of aneurysm in the target vessel/s 6. Presence of a stent in the target lesion 7. Prior vascular surgery of the target lesion. 8. Stroke or heart attack within 3 months prior to enrollment 9. Any planned surgical procedure or intervention performed within 30 days prior to or post index procedure 10. SFA or PPA disease in the opposite leg that requires treatment at the index procedure 11. Enrolled in another investigational drug, device or biologic study that interferes with the study 12. Life expectancy of less than one year 13. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure 14. Rutherford classification of 0, 1, 5 or 6. 15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy. 16. Platelet count \<100,000 mm3 or \>600,000 mm3 17. Receiving dialysis or immunosuppressant therapy 18. Pregnant or lactating females. 19. History of major amputation in the same limb as the target lesion 20. Chronic kidney disease (serum creatinine \> 3 mg/dL)