Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000295246p
Ethics application status
Not yet submitted
Date submitted
15/01/2018
Date registered
27/02/2018
Date last updated
27/02/2018
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
None
Universal Trial Number (UTN)
U1111-1207-7203
Trial acronym
SPEAR
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

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Diagnosis
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
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2018
Actual
Date of last participant enrolment
Anticipated
1/12/2019
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
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
Hospital
Name [1] 298392 0
John Hunter Hospital
Country [1] 298392 0
Australia
Funding source category [2] 298394 0
Commercial sector/Industry
Name [2] 298394 0
Abbott Australasia Pty. Ltd.
Country [2] 298394 0
Australia
Primary sponsor type
Individual
Name
Dr Arvind Deshpande
Address
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 297520 0
Hospital
Name [1] 297520 0
John Hunter Hospital
Address [1] 297520 0
Lookout Road, New Lambton Heights, NSW, 2305
Country [1] 297520 0
Australia

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
Australia
Date submitted for ethics approval [1] 299385 0
21/01/2018
Approval date [1] 299385 0
Ethics approval number [1] 299385 0

Summary
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
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 80242 0
Dr Arvind Deshpande
Address 80242 0
John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305
Country 80242 0
Australia
Phone 80242 0
+61 2 4921 3000
Fax 80242 0
Email 80242 0
[email protected]
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
Australia
Phone 80243 0
+61 2 4921 3000
Fax 80243 0
Email 80243 0
[email protected]
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
Australia
Phone 80244 0
+61 2 4921 3000
Fax 80244 0
Email 80244 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.