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

Inclusion Criteria

• Age ≥18 years.
• Subject has been informed of the nature of the study, agrees to participate and has signed an EC approved consent form.
• Female subjects of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation.
• Subject has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Clinical Category 4 or 5.
• Subjects with documented infection grade 0-2 and ischemia grade 2-3 according to WIfi classification.
• Life expectancy >1 year in the Investigator's opinion.
• Reference Vessel Diameter (RVD) 2 - 4 mm, and confirmed by DUS assessment.
• Total occlusions with total lesion length ≥ 40 mm (by visual estimate).
• Lesion must be located in the infrapopliteal arteries and above the ankle joint.
• Multiple lesions can be treated if located in separate vessels.
• Presence of documented run-off to the foot.
• Inflow free from flow-limiting lesion confirmed by angiography.
• Successful pre-dilatation of the (entire) target lesion.

Exclusion Criteria

• Subject unwilling or unlikely to comply to the appropriate follow-up times for the duration of the study.
• Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre or post-procedure.
• Lesion and/or occlusions located or extending in the popliteal artery or below the ankle joint space.
• Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, SFA and popliteal arteries left untreated.
• Failure to obtain ≤ 30% residual stenosis in pre-existing, hemodynamically significant inflow lesions in the ipsilateral iliac, SFA and popliteal artery.
• Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization.
• Previous DCB procedure in the target vessel within 6 months prior to index procedure.
• Aneurysm in the target vessel.
• Angiographic evidence of thrombus within target limb.
• Pre-dilatation resulted in major (≥ Grade D) flow-limiting dissection or residual stenosis > 30%.
• Use of alternative therapy e.g. atherectomy, cutting balloon, laser, radiation therapy, stents as part of target vessel treatment.
• Recent MI or stroke < 30 days prior to the index procedure.
• Heart failure with Ejection Fraction < 30%.
• Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound on the target limb.
• Subjects with infection grade 3 and ischemia grade 0 and 1 according to the Wifi classification.
• Subjects with neutrotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk of major amputation.
• Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement.
• Impaired renal function (GFR <20 mL/min) and patients on dialysis.
• Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica on active treatment.
• Patient receiving systemic corticosteroid therapy.
• 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.
• The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
• Female subjects who are breastfeeding at the time of enrollment.