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RECRUITING
NCT06332911

Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair

Sponsor: Rede Optimus Hospitalar SA

View on ClinicalTrials.gov

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

Interventions

DEVICE

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