ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"

  • End date
    Dec 31, 2027
  • participants needed
  • sponsor
    Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Updated on 23 April 2022


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.


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 pathologies with proximal landing at zone 0. The devices will be implanted at the discretion of the treating physician.

Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the branch stent graft systems for aortic arch (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®). Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.

The period of data collection will be approximately 60 months from the index procedure for each patient. Source document verification will be performed on 100% of patients; data from all visits will be reviewed and verified against existing source documents. Complete DICOM image files of the CT scans will be sent to the CoreLab for independent evaluation.

Condition Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis, Intramural Hematoma, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases
Treatment Endovascular exclusion
Clinical Study IdentifierNCT05309707
SponsorVascular Investigation Network Spanish Society for Angiology and Vascular Surgery
Last Modified on23 April 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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How to participate?

Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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