ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Trial Parameters
Brief Summary
The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0. The secondary objective is to evaluate the safety and clinical performance of the studied devices.
Eligibility Criteria
Inclusion Criteria: * Patient is between 18 and 90 years old * Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0. * Patient must be available for the appropriate follow-up times for the duration of the study * Informed consent signed. Exclusion Criteria: * Patient less than 18 years old or more than 90 years old. * Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium) * Patient has systemic infection or suspected systemic infection * Patient has thrombocytopenia (platelet count \< 150000/µl) * Patient has untreated hyperthyroidism * Patient has a progressive or untreated malignancy. * Patient is pregnant or breastfeeding. * Patient has a life expectancy of less than 1 year. * Not