Endovascular treatment for aortic arch pathologies in Spain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Spanish society for Angiology and Vascular Surgery
  Madrid, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.