JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon

Exclusion Criteria

• •1. Has one or more of the contraindications listed in the JetStream or Ranger IFUs.
• •2. Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used (that cannot be reasonably substituted).
• •3. Is expected to require cilostazol (Pletal) during the one-year follow-up period.
• •4. Has a hypersensitivity to contrast material that cannot be adequately pretreated.
• •5. Has known hypersensitivity to treatment device materials including paclitaxel or nitinol.
• •6. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
• •7. Has life expectancy of less than 24 months.
• •8. Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing.
• •9. Has surgical or endovascular procedure of the target vessel within 30 days prior to the index procedure.
• •10. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
• •11. Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.
• •12. Has any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
• •13. Has had a previous peripheral bypass affecting the target vessel (allowable for physician to pass through bypass graft in aorta-iliac region to get to the target lesion).
• •14. Has chronic renal insufficiency (eGFR \< 30 ml/min or creatinine ≥ 2.5 including dialysis patients).
• •15. Has planned laser, cryo, TurboHawk or any other treatment except study treatment within 30 days after the index procedure.
• •16. Has had superficial thrombophlebitis or deep venous thrombus within 30 days prior to index procedure.
• •17. Has had a stroke within 3 months prior to index procedure.
• •18. Has had a myocardial infarction within 1 month prior to index hospitalization
• •19. Has history of significant gastrointestinal bleeding in the past 2 months prior to index procedure, or any history of hemorrhagic diathesis.
• •20. Has a known or suspected systemic infection at the time of the index procedure.
• •21. Patients with ipsilateral Iliac and CFA disease are allowed in the study but these lesions have to be treated successfully first (\<30% residual) before patient can be enrolled. Treatment as per investigator's preference.
• •22. Aneurysm located in the target vessel or aneurysmal vessel
• •1. Has \< 70% stenosis prior to treatment of the target lesion.
• •2. Has in-stent restenosis of the target lesion.
• •3. Has an acute intraluminal thrombus within the target lesion.
• •4. Has an aneurysmal target vessel
• •5. Patient has already been enrolled in the study or any other study that by the investigator judgment may interfere with the outcome of this trial
• •6. Has two or more lesions that require treatment in the target vessel. Lesions have to be separated by \> 5 cm in order to be considered different lesions. Only one lesion per target vessel can be enrolled during the index procedure
• •7. Has disease that precludes safe advancement of the JS device to the target lesion.
• •8. P3 segments of the popliteal vessel.