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Prospective evaluation of a model to predict outcomes following Endovascular Aortic Aneurysm Repair (EVAR)

Prospective evaluation of an interactive model for endovascular aortic aneurysm repair (EVAR) developed to allow clinicians to preoperatively predcit the likelihood of individual failure based on perioperative & aneurysm-related mortality, need for reintervention, type I and II endoleaks and 3 year survival.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12609000371291
Enrollment
695
Registered
2009-05-27
Start date
2009-03-24
Completion date
2013-05-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary aim of this project is to prospectively evaluate and improve an interactive model for predicting outcomes for individual patients following endovascular aortic aneurysm repair (EVAR). The model was developed to allow clinicians to preoperatively predict the likelihood of individual failure based on the following outcomes: perioperative and aneurysm-related mortality, need for reintervention, type I & III endoleaks and 3 year survival. The secondary aim is to assess whether specific biomarkers are able to predict the incidence of postoperative EVAR failure and hence contribute to the predictive model. This study will include 1000 patients who require elective, non-urgent EVAR repair, recruited at multiple sites over a 2 year period. Data will be collected for a minimum of 3 years from the time a patient is enrolled into the study. Active endovascular surgeons at participating hospitals will be responsible for ensuring the data submission forms are completed for the duration of patient involvement in the study. The University of Adelaide, Department of Surgery in Adelaide, will administer the study and assign a team of data coordinators, researchers, statisticians, and programmers to undertake this study. Data will be collected preoperatively, immediately post-operatively and at follow up. Patients will be reviewed at 30-days and at six months post-operatively, and then annually for three years. Biomarkers will also be collected pre-operatively and at each follow up vsit for the duration of the study.

Interventions

This study does not evaluate the EVAR procedure, but rather obtain detailed information in order to further refine the existing predictive model. Participants in this study will require elective, non-urgent EVAR repair. Participants will attend a pre-opreative appointment, followed by a post-operative review within 6 weeks of EVAR, at 6 months and then follow up appointments annually for three years. Biomarkers will be collected pre-operatively and at every follow up visit to assess whether sp

This study does not evaluate the EVAR procedure, but rather obtain detailed information in order to further refine the existing predictive model. Participants in this study will require elective, non-urgent EVAR repair. Participants will attend a pre-opreative appointment, followed by a post-operative review within 6 weeks of EVAR, at 6 months and then follow up appointments annually for three years. Biomarkers will be collected pre-operatively and at every follow up visit to assess whether specific biomarkers are able to predict the incidence of postoperative EVAR failure and hence contribute further to the predictive model.

Sponsors

NHMRC
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-Individuals 50 years of age or older -Elective and non-urgent EVAR repair -All propriety brands, cases in which fenestrated or branch grating is performed

Exclusion criteria

-Ruptured aneurysms -patients who are mentally or intellectually impaired and cannot make an informed decision

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026