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Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Sponsor: Rede Optimus Hospitalar SA
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.
Official title: International Multi-center Study to Confirm the Safety and Performance of the Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
30
Start Date
2025-05-19
Completion Date
2027-05-30
Last Updated
2025-05-23
Healthy Volunteers
No
Conditions
Interventions
Shockwave™ 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