RecruitingNCT06332911

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Sponsor

Rede Optimus Hospitalar SA

Enrollment

30 participants

Start Date

May 19, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+ for people with abdominal aortic aneurysm without rupture, thoracic aortic aneurysm without rupture, and other related conditions. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEShockwave™ Peripheral Intravascular Lithotripsy Balloon M5+

Cracking-not-debulking technique (SHOCKWAVE IVL)

Locations(5)

Department of Vascular Surgery, LMU Hospital Munich

Münich, Bavaria, Germany

Department of Vascular Surgery, Klinikum Nürnberg Campus Süd

Nuremberg, Bavaria, Germany

University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM

Genoa, Liguria, Italy

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Veneto, Italy

Inselspital, University Hospital Bern, Heart Vascular Center

Bern, Canton Bern, Switzerland

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NCT06332911

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