Status:
RECRUITING
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Lead Sponsor:
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Conditions:
Thoracic Aortic Aneurysm
Thoracic Aortic Dissection
Eligibility:
All Genders
18-90 years
Brief 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 s...
Detailed Description
In this study patients will be observed, who receive a branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®) for the endovascular treatment of aortic arch ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05309707
Start Date
January 1 2022
End Date
December 31 2027
Last Update
April 4 2022
Active Locations (1)
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1
Spanish society for Angiology and Vascular Surgery
Madrid, Spain, 28006