Endovascular treatment for aortic arch pathologies in Spain
ENDOBARC-S Study: "Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain"
Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery · NCT05309707
This study is testing if special stent devices can help people aged 18 to 90 with serious aortic arch problems live longer and stay safe.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery (network) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05309707 on ClinicalTrials.gov |
What this trial studies
The ENDOBARC-S study is an observational follow-up that evaluates the effectiveness of branch stent graft systems in preventing death related to aortic arch pathologies. Patients aged 18 to 90 with conditions such as thoracic aortic aneurysm or dissection will be treated with devices like the Nexus stent-graft system or Relay Branch. Data will be collected over approximately 60 months, with physicians documenting their observations during routine care. The study aims to assess both the safety and clinical performance of these devices.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 90 with specific aortic arch pathologies who are undergoing treatment with branch stent graft systems.
Not a fit: Patients with systemic infections, untreated malignancies, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce mortality associated with aortic arch pathologies.
How similar studies have performed: Other studies have shown promise with similar endovascular approaches, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Madrid
- Spanish society for Angiology and Vascular Surgery — Madrid, Spain (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis, Intramural Hematoma, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases