ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
100 participants
Jan 1, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria9
- 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 informed consent signed
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Interventions
Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.
Locations(1)
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NCT05309707