Actively Recruiting
Observational Study of Branch Stent Grafts for Treating Aortic Arch Diseases in Adults Aged 18 to 90 in Spain
Led by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery · Updated on 2022-04-04
100
Participants Needed
1
Research Sites
260 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the prevention of death related to aortic arch pathologies in patients treated with branch stent graft systems such as the Nexus stent-graft system4, Relay Branch4, or Zenith arch branch graft4, with the device landing in zone 0 of the aorta. The study also looks at the safety and clinical performance of these devices in managing aortic arch diseases like aneurysms, dissections, and other vascular conditions. Patients undergoing treatment with these branch stent graft systems will be observed as part of routine care. The devices are implanted based on physician decision, and data will be collected over about 60 months following the procedure. Data verification includes review of clinical records and independent evaluation of CT scan images by a CoreLab to assess device and patient outcomes. Participants will have their medical records monitored throughout the follow-up period, with assessments including mortality rates at multiple time points up to 60 months, major adverse events, device integrity, reinterventions, and aneurysm size changes. The study collects detailed clinical and imaging data to track the performance and safety of the stent grafts over time.
CONDITIONS
Brief Title
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
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