NCT05309707

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jan 2022Dec 2027

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

March 24, 2022

Last Update Submit

March 24, 2022

Conditions

Thoracic Aortic AneurysmThoracic Aortic DissectionStent-Graft EndoleakStent-Graft StenosisIntramural HematomaAortic DiseasesCardiovascular DiseasesVascular Diseases

Keywords

AortaThoracic aortic aneurysmThoracic aorta dissectionEndovascular repair

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Rate of all-cause mortality

    30 days

Secondary Outcomes (21)

  • Mortality

    24 hours

  • Mortality

    3-6, 12, 24, 36, 48, 60 months

  • Rupture

    3-6, 12, 24, 36, 48, 60 months

  • Major Adverse Events (MAE)

    prior to discharge, 30 days, 3-6, 12, 24, 36, 48, 60 months

  • Number of interventions

    Perioperative

  • +16 more secondary outcomes

Study Arms (1)

Patients with aortic arch pathologies treated by branch stent graft systems

Patients with aortic arch pathologies treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.

Device: Endovascular exclusion

Interventions

Endovascular exclusionDEVICE

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

Patients with aortic arch pathologies treated by branch stent graft systems

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with aortic arch pathologies (aneurysm, pseudoanerysm, 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish society for Angiology and Vascular Surgery

Madrid, 28006, Spain

RECRUITING

Related Links

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicDissection, Thoracic AortaAortic DiseasesCardiovascular DiseasesVascular Diseases

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmAortic DissectionDissection, Blood VesselAcute Aortic Syndrome

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2022

First Posted

April 4, 2022

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion (Estimated)

December 31, 2027

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Data analyzed by core lab

Locations

ES(1)