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
260 weeks
Total Duration
On this page
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"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is between 18 and 90 years old
- Patient has aortic arch pathologies such as aneurysm, pseudoaneurysm, dissection, penetrating ulcer, or intramural hematoma
- Patient has been treated with branched stent-grafts (Nexus stent graft system4, Relay4 Branch, or Zenith arch branch graft4) with proximal landing at zone 0
- Patient is available for follow-up for the duration of the study
- Informed consent has been signed
You will not qualify if you...
- Patient is younger than 18 or older than 90 years old
- Patient has allergies to materials used in endovascular repair such as contrast media, anticoagulants, heparin, nitinol, polyester, gold, or platinum-iridium
- Patient has systemic or suspected systemic infection
- Patient has thrombocytopenia (platelet count less than 150000/�b5l)
- 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
- Informed consent has not been signed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Index procedure day
Participants receive branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) implanted at the discretion of their treating physician as part of routine care for aortic arch pathologies.
1 procedure visit
Duration - Approximately 60 months
Participants are observed during routine follow-up visits for up to approximately 60 months after the procedure to monitor outcomes including mortality, aneurysm status, and device performance.
Follow-up visits at 30 days, 3-6 months, 12, 24, 36, 48, and 60 months
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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