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.
Standardized forms will collect data on the performed procedure, underlying pathology, cardiovascular risks and information on preoperative examinations. Physiological parameters routinely measured prior, during and after any surgical intervention will be recorded as well. A 1 month, 6-months and 12-months follow-up visit will be conducted to assess adverse events and outcome of the index procedure. In addition, this study aims to analyze the technical and procedure success to gain access via hostile iliac access vessels withShockwave Peripheral Intravascular Lithotripsy Balloon in patients submitted for complex endovascualre thoracic, throaco-abdominal or abdominal aortic repair.
Study Type
OBSERVATIONAL
Enrollment
30
Cracking-not-debulking technique (SHOCKWAVE IVL)
Department of Vascular Surgery, LMU Hospital Munich
Münich, Bavaria, Germany
RECRUITINGDepartment of Vascular Surgery, Klinikum Nürnberg Campus Süd
Nuremberg, Bavaria, Germany
RECRUITINGUniversity of Genoa School of Medicine, Ospedale Policlinico San Martino - HSM
Genoa, Liguria, Italy
RECRUITINGAzienda Ospedaliera Universitaria Integrata di Verona
Verona, Veneto, Italy
RECRUITINGInselspital, University Hospital Bern, Heart Vascular Center
Bern, Canton Bern, Switzerland
NOT_YET_RECRUITINGEfficacy: Technical success - defined as intention-to-treat basis
* 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
Time frame: 30 days
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