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Trial registered on ANZCTR


Registration number
ACTRN12609000371291
Ethics application status
Approved
Date submitted
12/03/2009
Date registered
27/05/2009
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Date results information initially provided
4/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective evaluation of a model to predict outcomes following Endovascular Aortic Aneurysm Repair (EVAR)
Scientific title
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.
Secondary ID [1] 297601 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 4462 0
Condition category
Condition code
Surgery 4729 4729 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 4205 0
Not applicable
Comparator / control treatment
No control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5600 0
To prospectively evaluate and improve an interactive model for endovascular aortic aneurysm repair (EVAR) developed to allow clinicians to preoperatively predict the likelihood of individual failure based on perioperative and aneurysm-related mortality, need for reintervention, type I & III endoleaks and survival.
Participants will undergo detailed vascular assessments at the preoperative appointment, and at each follow up. Participants will also have a Computed Tomography (CT) or Ultrasound performed at every visit, standard blood tests +/- biomarkers and concomitant medication and adverse event assessment.
Timepoint [1] 5600 0
Up to 3 years post-EVAR
Secondary outcome [1] 9427 0
To assess whether specific biomarkers are able to predict the incidence of postoperative EVAR failure and hence contribute to the predictive model.
Participants who elect to undertake this separate component of the study will have blood samples taken pre-operatively, and at every follow up appointment. Blood samples will be analysed by Professor Jonathan Golledge, James Cook University.
Timepoint [1] 9427 0
3 years post-EVAR

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Ruptured aneurysms

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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Multinomial logistic regression determined which preoperative variables best predicted each outcome. Area under Receiver Operating Characteristic curve (ROC), model p-value and internal validation statistics were used to select the best model.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment outside Australia
Country [1] 1676 0
United Kingdom
State/province [1] 1676 0

Funding & Sponsors
Funding source category [1] 4652 0
Government body
Name [1] 4652 0
Natinal Health and Medical Research Council (NHMRC)
Address [1] 4652 0
GPO Box 1421
Canberra ACT 2601
Country [1] 4652 0
Australia
Primary sponsor type
Government body
Name
NHMRC
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 4199 0
None
Name [1] 4199 0
Address [1] 4199 0
Country [1] 4199 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6688 0
Central Northern Adelaide Health Service Ethics of Human Research Committee
Ethics committee address [1] 6688 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville SA 5011
Ethics committee country [1] 6688 0
Australia
Date submitted for ethics approval [1] 6688 0
27/10/2008
Approval date [1] 6688 0
09/12/2008
Ethics approval number [1] 6688 0
2008162

Summary
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.
Trial website
Website not available
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29384 0
Prof Robert Fitridge
Address 29384 0
Discipline of Surgery,
The University of Adelaide,
The Queen Elizabeth Hospital,
Woodville South,
South Australia 5011
Country 29384 0
Australia
Phone 29384 0
+61 8222 7711
Fax 29384 0
=61 8 8222 6082
Email 29384 0
robert.fitridge@adelaide.edu.au
Contact person for public queries
Name 12631 0
Prof Robert Fitridge
Address 12631 0
Discipline of Surgery,
The University of Adelaide,
The Queen Elizabeth Hospital,
Woodville South,
South Australia 5011
Country 12631 0
Australia
Phone 12631 0
+61 8 8222 7711
Fax 12631 0
+61 8 8222 6082
Email 12631 0
robert.fitridge@adelaide.edu.au
Contact person for scientific queries
Name 3559 0
Prof Robert Fitridge
Address 3559 0
Discipline of Surgery,
The University of Adelaide,
The Queen Elizabeth Hospital,
Woodville South,
South Australia 5011
Country 3559 0
Australia
Phone 3559 0
+61 8 8222 7711
Fax 3559 0
+61 8 8222 6082
Email 3559 0
robert.fitridge@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Our patient data is potentially identifiable, therefore for reasons of confidentiality, the data will not be available. However, data dictionaries are available on request.
What supporting documents are/will be available?
Other
'Other' documents specified
The interactive Excel spreadsheet which provides the facility to carry out predictive modelling on patients before surgery has been deposited on Figshare and is freely available to download using the following URL; https://doi.org/10.6084/m9.figshare.7121777.v1
How or where can supporting documents be obtained?
Type [1] 1465 0
Other
Citation [1] 1465 0
Link [1] 1465 0
Email [1] 1465 0
Other [1] 1465 0
https://doi.org/10.6084/m9.figshare.7121777.v1
Attachment [1] 1465 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
This trial has updated a risk assessment model which helped inform patients of possible outcomes and complications before they undergo endovascular aneurysm repair (EVAR). The results from the current trial have allowed the development of a new easy-to-use predictive model. Ten preoperative clinical and anatomical factors are entered into the software which then calculates the percentage likelihood of complications after surgery. This knowledge can be used for discussion between the patient and the surgeon at the preoperative consultation to assist in shared-decision making between the patient and surgeon. Of particular note is the finding that self-reported fitness contributes significantly to outcomes after EVAR surgery, with fit patients having a much lower risk of early or late death after EVAR.