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

NCT05755412 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2026-03-25

No results posted yet for this study

Summary

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).

Conditions

  • Peripheral Arterial Disease
  • Critical Limb-Threatening Ischaemia

Sponsors & Collaborators

  • Fondazione Italiana Vascolare

    collaborator OTHER

  • EndoCore Lab s.r.l.

    lead OTHER

Principal Investigators

  • Mariano L Palena, MD · Casa di Cura Abano Terme

  • Pierluigi Antignani, MD · Fondazione Vascolare Italiana

  • Gabriele Morselli, PharmD · EndoCoreLab s.r.l.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2024-08-30
Completion
2025-08-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05755412 on ClinicalTrials.gov