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

Launched by VASCULAR INVESTIGATION NETWORK SPANISH SOCIETY FOR ANGIOLOGY AND VASCULAR SURGERY · Mar 24, 2022

Keywords

ClinConnect Summary

The ENDOBARC-S study is investigating the use of special devices called branched stent-grafts to treat serious problems related to the aortic arch, which is a part of the heart's main blood vessel. This trial aims to see if these devices can help prevent death caused by conditions like aortic aneurysms or dissections, and it also looks at how safe and effective these treatments are. If you're between 18 and 90 years old and have one of these aortic issues, you may be eligible to participate in this study.

Participants will receive treatment with one of the stent-graft systems and will need to attend follow-up appointments to monitor their health over time. It’s important to note that certain conditions, such as allergies to the materials used in the devices or serious infections, may prevent someone from being eligible. If you or a loved one are considering joining this study, you'll need to provide informed consent and will be guided through the process by the study team.

Gender

ALL

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 informed consent signed