Actively Recruiting
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies 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
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is between 18 and 90 years old
- Patient has aortic arch pathologies including aneurysm, pseudoaneurysm, dissection, penetrating ulcer, or 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 follow-up during the study
- Patient has signed informed consent
You will not qualify if you...
- Patient is younger than 18 or older than 90 years
- Patient has allergies to materials needed for endovascular repair such as contrast media, anticoagulants, heparin, nitinol, polyester, gold, or platinum-iridium
- Patient has systemic infection or suspected systemic infection
- Patient has thrombocytopenia (platelet count less than 150000/µl)
- Patient has untreated hyperthyroidism
- Patient has progressive or untreated malignancy
- Patient is pregnant or breastfeeding
- Patient has a life expectancy less than 1 year
- Patient has not signed informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Spanish society for Angiology and Vascular Surgery
Madrid, Spain, 28006
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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