ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Recruiting now
Conditions studied: Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis, Intramural Hematoma, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases
In brief
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.
Key facts
- Study ID
- NCT05309707
- Run by
- Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
- People needed
- 100
- Starts
- 2022-01-01
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2022-04-04
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Spanish society for Angiology and Vascular Surgery — Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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