IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Exclusion Criteria

• •1. Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
• •2. Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
• •3. Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
• •4. Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
• •5. Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
• •6. Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
• •7. Previous DCB procedure in the target vessel within 6 months prior to index procedure.
• •8. Aneurysm in the target vessel.
• •9. Angiographic evidence of thrombus within target limb.
• •10. Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis \> 30%.
• •11. Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
• •12. Recent MI or stroke \< 30 days prior to the index procedure.
• •13. Heart failure with Ejection Fraction \< 30%.
• •14. Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
• •15. Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.
• •16. Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
• •17. Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
• •18. Impaired renal function (GFR \<20 mL/min) and patients on dialysis.
• •19. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
• •20. Patient receiving systemic corticosteroid therapy.
• •21. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• •22. The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
• •23. Female subjects who are breastfeeding at the time of enrollment.