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Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

NCT06332911 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-05-23

No results posted yet for this study

Summary

Shockwave TEVAR is a nonrandomized, prospective, international, multi-center, PMCF, obervational study.

The aim of this study is to evaluate the outcomes of the Shockwave™ Peripheral Intravascular Lithotripsy Balloon (Shockwave Medical Inc.) in the routine treatment of hostile iliac accesses during TEVAR and F/BEVAR.

Conditions

  • Thoracoabdominal Aortic Aneurysm, Without Mention of Rupture
  • Abdominal Aortic Aneurysm Without Rupture
  • Thoracic Aortic Aneurysm Without Rupture

Interventions

DEVICE

Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Cracking-not-debulking technique (SHOCKWAVE IVL)

Sponsors & Collaborators

  • Shockwave Medical, Inc.

    collaborator INDUSTRY

  • Rede Optimus Hospitalar SA

    lead NETWORK

Principal Investigators

  • Marc Bosiers, Dr. · Rede Optimus Hospitalar AG

  • Nikolaos Tsilimparis, Prof. · Department of Vascular Surgery, LMU Hospital Munich

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2026-05-30
Completion
2027-05-30

Countries

  • Germany
  • Italy
  • Switzerland

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 NCT06332911 on ClinicalTrials.gov