Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)

The study will evaluate the safety and efficacy of Peripheral Intravascular Lithotripsy system with Shockwave S4 catheter® for the treatment of de novo, re-stenosis or re-occlusive,calcified chronic total occlusion (CTOs) lesions in patients with Critical Limb Threatening Ischemia (CLTI).

Inclusion Criteria:Age ≥18 yearsPatient has signed an approved informed consent formPatient with Critical Limb Ischaemia, Rutherford category 4 (ischaemic rest pain), 5(minor tissue loss) or 6 (major tissue loss)Patient with Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal arteryThe vascular lesion length will be no longer than 150 mm.Patient with no significant disease at the inflow: common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to enrollment, and patient with no significant disease at the outflow - runoff to ankle level: plantar for posterior tibial, pedal for anterior tibial, anterior and posterior perforant branches for peroneal vessels or previous successful revascularization of the disease segments (inflow-outflow)Live expectancy > 1 year.Presence at least ≥1 filling pedal vessel on the target limb.Exclusion Criteria:Subject pregnant or planning to become pregnant during the studySubject no able to perform the follow up or other factors making clinical follow-up difficultAcute or Subacute limb ischaemia which requires thrombolysis as first treatment modality or previous thrombolytic therapy in the last 48-72 hours.Known allergy to concomitant medication, antiplatelet anti-coagulant or thrombolytic medicationPoor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteriesSignificant stenoses (> 50%) distal to the target lesion that might require revascularization or impede run-offDesert foot condition. No Patent foot main arteriesSubject enrolled in another investigational study that has not reached its primary endpoint