Shockwave™Peripheral Intravascular Lithotripsy Balloon for Advanced Endovascular Aortic Repair
Condition(s) studied
Investigational drug(s) / intervention(s)
Shockwave™ Peripheral Intravascular Lithotripsy Balloon M5+: Cracking-not-debulking technique (SHOCKWAVE IVL)
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.
Eligibility
Primary outcome measure(s)
- Efficacy: Technical success - defined as intention-to-treat basis — 30 days
* Successful dilatation of the access vessels to 8mm without rupture * Successful endovascular access and deployment of all aortic devices * Performance of the Shockwave™ IVL: Includes the definition for technical success as well as delivery of the intended main endograft without the need for surgical conversion, arterial rupture and iliac artery occlusion
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Department of Vascular Surgery, LMU Hospital Munich | Münich | Bavaria | Recruiting |
| Department of Vascular Surgery, Klinikum Nürnberg Campus Süd | Nuremberg | Bavaria | Recruiting |
| University of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM | Genoa | Liguria | Recruiting |
| Azienda Ospedaliera Universitaria Integrata di Verona | Verona | Veneto | Recruiting |
| Inselspital, University Hospital Bern, Heart Vascular Center | Bern | Canton Bern | Not Yet Recruiting |
More Rede Optimus Hospitalar SA trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06332911 on ClinicalTrials.gov ↗ ← All trials in Italy