NCT05309707 ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
| NCT ID | NCT05309707 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery |
| Condition | Thoracic Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2023-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-01-01 with a primary completion date of 2023-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05309707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Thoracic Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05309707 currently recruiting?
Yes, NCT05309707 is actively recruiting participants. Visit ClinicalTrials.gov or contact Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery to inquire about joining.
Where is the NCT05309707 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT05309707 clinical trial?
NCT05309707 is sponsored by Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery. The trial plans to enroll 100 participants.