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Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access

NCT05880641 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-03-25

No results posted yet for this study

Summary

The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices in iliac calcified access.

Conditions

  • Aortic Diseases
  • Aorto-Iliac Atherosclerosis
  • Peripheral Arterial Disease

Sponsors & Collaborators

  • Fondazione Italiana Vascolare

    collaborator OTHER

  • EndoCore Lab s.r.l.

    lead OTHER

Principal Investigators

  • Stefano Fazzini, MD · Fondazione PTV - Policlinico Tor Vergata

  • Pierluigi Antignani, MD · Fondazione Italiana Vascolare (FIV)

  • Gabriele Morselli, PharmD · EndoCore Lab

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2027-08-31
Completion
2027-09-30

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 NCT05880641 on ClinicalTrials.gov