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Recruiting NCT05309707

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

— Observational Thoracic Aortic Aneurysm Thoracic Aortic Dissection Stent-Graft Endoleak Stent-Graft Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endovascular exclusion.
Who it may be relevant to
Registry conditions: Thoracic Aortic Aneurysm, Thoracic Aortic Dissection, Stent-Graft Endoleak, Stent-Graft Stenosis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Device Endovascular exclusion
    Endovascular exclusion by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

Primary outcome measures

  • Mortality [Time frame: 30 days]
Secondary outcome measures (12)
  • Mortality [Time frame: 24 hours]
  • Mortality [Time frame: 3-6, 12, 24, 36, 48, 60 months]
  • Rupture [Time frame: 3-6, 12, 24, 36, 48, 60 months]
  • Major Adverse Events (MAE) [Time frame: prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months]
  • Number of interventions [Time frame: Perioperative]
  • Delivery time [Time frame: Perioperative]
  • Reintervention [Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months]
  • Endoleak [Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months]
  • Proximal intercomponent separation [Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months]
  • Integrity [Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months]
  • Kinking [Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months]
  • Primary patency [Time frame: 30 days, 3-6, 12, 24, 36, 48, 60 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Spanish society for Angiology and Vascular Surgery — Madrid

Identifiers

NCT: NCT05309707 · 2022-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗