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Trial registered on ANZCTR

Registration number
Ethics application status
Not yet submitted
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Sac Pressure in Endovascular Aneurysm Repair (SPEAR) trial
Scientific title
A Prospective Validation study of the Utility of Intra-Aortic Aneurysm Sac Pressure Measurements as a Predictor of Endoleak and further intervention in Patients undergoing Endovascular Aortic Aneurysm Repair (EVAR)
Secondary ID [1] 293776 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Aneurysms 306171 0
Endoleak 306172 0
Condition category
Condition code
Surgery 305283 305283 0 0
Surgical techniques
Cardiovascular 305340 305340 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
Intra-sac pressure monitoring will be performed during endovascular aortic aneurysm repair (EVAR). The procedure will be performed by an experience Vascular surgeon. The pressure will be measured using a pressure transducing catheter that will be introduced at the start of the case through a separate femoral micro-puncture. The pressure will be measure at pre-defined intervals; before deployment of the stent graft, after deployment of the stent graft, after balloon moulding of the stent graft and after administration of protamine if it is given at the end of the case. The results will be correlated with any ability to predict continued endoleak or endotension at the completion of the procedure and upon follow up for 24 months.
Intervention code [1] 300030 0
Treatment: Devices
Comparator / control treatment
No control group
Control group

Primary outcome [1] 304441 0
The presence or absence of endoleak at completion of procedure measured on angiography or on ultrasound.
Timepoint [1] 304441 0
Assessment for endoleak or endotension will be performed before discharge, prior to 6 weeks to 3 months follow-up, prior to 6 month follow-up, prior to 12 months follow-up and prior to 24 months follow-up. The primary time-point is 12 months. All assessments for endoleak and endotension will be performed a maximum of 2 weeks before the scheduled follow-up appointment.
Secondary outcome [1] 341942 0
Aneurysm sac diameter measured on pre-operative ultrasound and CT and on ultrasound.
Timepoint [1] 341942 0
The secondary time-point is 12 and 24 months.
Secondary outcome [2] 341943 0
The need for re-intervention of any type due to type I or type III endoleaks or continued aneurysm sac growth. The need for re-intervention will be made during the course of clinical follow-up and is at the discretion of the treating surgeon. The diagnosis of endoleaks or continued aneurysm growth after the procedure will be made by the Vascular surgeons on the basis of ultrasound by experienced vascular sonographers and by fine slice contrast CT scans.
Timepoint [2] 341943 0
The secondary time-point is 12 and 24 months.
Secondary outcome [3] 341944 0
Post-operative surgical complications graded by the Clavien-Dindo Classification of Surgical Complications up to day 30 post-op. The data for this will be collected through medical records or noted by the treating vascular surgeon.
Timepoint [3] 341944 0
Complications within the first 30 days as assessed by medical records or noted by the treating vascular surgeon.

Key inclusion criteria
All patients over the age of 18 years of age who are undergoing elective or semi-urgent booked endovascular aortic aneurysm repair at the John Hunter Hospital.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients from the above group will be excluded if they:
• are under 18 years of age, or
• refuse or are unable to give written informed consent to participate in the study, or
• are unable to understand verbal and written consent documentation due to English not being the primary language, or
• have severe renal impairment, or
• severe allergy to iodine contrast which contraindicated endovascular repair, or
• require a thoraco-abdominal aneurysm repair, or
• pregnant or lactating females

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There is no allocation concealment as the intervention is performed on all participants by the treating team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-randomised trial
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The primary outcome, the presence or absence of endoleaks at 12 months follow-up is a binary measurement based on ultrasound and CT imaging findings. The predictive performance of the intra-sac pressure measurements (and changes in these between pre- and post-surgery) will be assessed through a logistic regression model. Predictive performance will be measured using the AUC (and will be adjusted for internal optimism bias using bootstrap re-sampling). Model calibration will be assessed using Hosmer-Lemeshow’s test as well as graphical methods. A model including patient level characteristics will also be assessed and compared to the model including patient characteristics and intra-sec pressure. Mixed effects linear regression models will be used to assess the relationship between sac pressure and sac diameter measured at each follow-up time point.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 9753 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 18531 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 298392 0
Name [1] 298392 0
John Hunter Hospital
Address [1] 298392 0
Lookout Road, New Lambton Heights, NSW, 2305
Country [1] 298392 0
Funding source category [2] 298394 0
Commercial sector/Industry
Name [2] 298394 0
Abbott Australasia Pty. Ltd.
Address [2] 298394 0
299 Lane Cove Road
Macquarie Park, NSW 2113
Country [2] 298394 0
Primary sponsor type
Dr Arvind Deshpande
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Secondary sponsor category [1] 297520 0
Name [1] 297520 0
John Hunter Hospital
Address [1] 297520 0
Lookout Road, New Lambton Heights, NSW, 2305
Country [1] 297520 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299385 0
Hunter New England HREC
Ethics committee address [1] 299385 0
Hunter New England Health
Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 299385 0
Date submitted for ethics approval [1] 299385 0
Approval date [1] 299385 0
Ethics approval number [1] 299385 0

Brief summary
Endovascular aortic aneurysm repair (EVAR) is being performed at an increasing rate in both the elective and emergency settings. The lower immediate morbidity and mortality rates of EVAR have been influential in the rapid adoption of this technique. However, the need for ongoing monitoring and higher rates of subsequent re-intervention that are required remain a concern for Vascular surgeons. The ability to be able to identify and predict the patient group most likely to require such re-interventions would be highly beneficial to rationalising treatment for patients. Intra-operative pressure measurements of the aneurysm sac is one method that may be able to guide therapy and this study is an extension of the currently mixed evidence surrounding this area.

The primary aim will be to assess if intra-sac pressure measurements (and changes in these measurements) can predict the development of intra-operative or persistent endoleaks or continued aneurysm sac enlargement. The intra-sac pressure measurements will be measured in terms of reduction in systolic and diastolic pressures as well as pulse pressure and as a ratio to the systemic circulation pressure. The progress of the aneurysm sac post-operatively will be monitored through the usual follow-up procedure of ultrasounds at regular intervals. If any persistent endoleaks are detected or there is continued sac enlargement then Computed Tomography (CT) with contrast injection or conventional angiography will be performed to further delineate the pathology.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 80242 0
Dr Arvind Deshpande
Address 80242 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 80242 0
Phone 80242 0
+61 2 4921 3000
Fax 80242 0
Email 80242 0
Contact person for public queries
Name 80243 0
Dr Joel Petit
Address 80243 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 80243 0
Phone 80243 0
+61 2 4921 3000
Fax 80243 0
Email 80243 0
Contact person for scientific queries
Name 80244 0
Dr Joel Petit
Address 80244 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 80244 0
Phone 80244 0
+61 2 4921 3000
Fax 80244 0
Email 80244 0

No information has been provided regarding IPD availability
Summary results
No Results