Shockwave ®S4 Catheter IVL to Treat Infrapopliteal Calcified Stenoses and/or Occlusions in CLTI Patients (LEGACY)
Reason given: Low Enrollment rate: The study targeted a highly selected and complex patient population, making the identification and enrollment of eligible patients particularly challenging for all participating centers
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Trial details
- Who runs it
- EndoCore Lab s.r.l.
- Trial code
- NCT05755412
- Record updated
- 25 March 2026
- Original description
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).Read full original descriptionShow less
Observational, Prospective, Single-arm Multicentric Study of Shockwave ®S4 Catheter IVL (Intravascular Lithotripsy) Balloon for the Treatment of Infrapopliteal Calcified Stenoses and/or Occlusions in Patients With Critical Limb Ischaemia
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: 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 tibial artery 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 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: Acute 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 medication; Desert foot condition. No Patent foot main arteries; Subject pregnant or planning to become pregnant during the study; Subject no able to perform the follow up or other factors making clinical follow-up difficult; Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries; Significant stenoses (> 50%) distal to the target lesion that might require revascularization or impede run-off; Subject enrolled in another investigational study that has not reached its primary endpoint.