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

Inclusion Criteria:

• Age ≥18 years

• Patient has signed an approved informed consent form

• Patient 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 tibialartery and the peroneal artery

• The 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 toenrollment, and patient with no significant disease at the outflow - runoff to anklelevel: plantar for posterior tibial, pedal for anterior tibial, anterior andposterior perforant branches for peroneal vessels or previous successfulrevascularization 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 study

• Subject no able to perform the follow up or other factors making clinical follow-updifficult

• Acute or Subacute limb ischaemia which requires thrombolysis as first treatmentmodality or previous thrombolytic therapy in the last 48-72 hours.

• Known allergy to concomitant medication, antiplatelet anti-coagulant or thrombolyticmedication

• Poor inflow due to ipsilateral stenoses or occlusions of the iliac orfemoropopliteal arteries

• Significant stenoses (> 50%) distal to the target lesion that might requirerevascularization or impede run-off

• Desert foot condition. No Patent foot main arteries

• Subject enrolled in another investigational study that has not reached its primaryendpoint