Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular

Inclusion Criteria

• Males or non-pregnant females ≥ 18 years of age at the time of consent. Females of childbearing potential have a negative pregnancy test 70% or chronic total occlusion (CTO)
• Infrapopliteal lesion: P3 to the ankle-joint level (not below-the-ankle (BTA)); full length lesions or tandem lesions are allowed
• Wound, Ischemia, foot Infection (WIfI) tissue loss grade 1-2 at baseline
• WIfI foot infection grade of 0-2 at baseline
• WIfI ischemia grade 2-3 at baseline
• Estimated life expectancy ≥ 1 year
• Multiple lesions can be treated if they are located in separate vessels per standard of care but only one (1) BTK vessel can be considered as the target lesion/vessel and need to be treated according the Clinical Investigation Protocol (CIP) guidelines.
• Target vessel should give direct or indirect run-off to the foot (clearly documented in a foot/BTA angiogram)
• Patients with in-flow lesions can be included if the lesions are treated successfully (residual stenosis ≤30%) with the same drug coated balloon (DCB) platform, bail-out stenting with a bare-metal stent (BMS).
• Successful pre-dilatation of the target lesion (≤30% residual stenosis)

Exclusion Criteria

• Previous bypass graft in the target limb
• Acute limb ischemia, defined as symptom onset during less than 14 days prior to the index procedure
• Prior or planned above-the-ankle amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridement)
• Previous DCB treatment in target vessel 6 months prior to index procedure
• WIfI tissue loss grade 0 or 3 at baseline
• WIfI foot infection grade 3 at baseline
• WIfI ischemia grade 0-1 at baseline
• Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12.000/or febrile state or C reactive protein (CRP)>5mg/L
• Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb within 30 days after the index procedure
• Existing stent implant in the target vessel
• Use of alternative therapies: atherectomy, cutting/scoring balloons, laser, …
• Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80.000/μL or greater than 500.000/μL
• Any subject in which antiplatelet, anticoagulant or thrombolytic therapy is contraindicated
• Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the index procedure
• History of stroke or transient ischemic attack (TIA) less than 90 days prior to the index procedure
• Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
• Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up
• Patients on haemodialysis
• Known hypersensitivity or allergy to contrast agents that cannot be medically managed
• Known hypersensitivity or allergy to heparin, aspirin, paclitaxel, clopidogrel or other antiplatelet/anticoagulant therapies
• Inadequate inflow lesion treatment (>30% residual stenosis)
• Inadequate result of pre-dilatation (>30% residual stenosis)
• Inadequate run-off to the foot
• Bilateral BTK enrolment in this study