ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorVascular Investigation Network Spanish Society for Angiology and Vascular Surgery

About this trial

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

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Endovascular exclusion

Treatment groups

100 Participants
are divided into 1 treatment group