Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000492257
Ethics application status
Approved
Date submitted
11/02/2018
Date registered
4/04/2018
Date last updated
4/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Endovascular repair of abdominal aortic aneurysms with hostile necks using the Ovation™ Device
Scientific title
Endovascular treatment of infrarenal abdominal aortic aneurysms with hostile neck features using the Ovation™ Device
Secondary ID [1] 294019 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal aortic aneurysm 306544 0
Condition category
Condition code
Cardiovascular 305644 305644 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endovascular aortic repair (EVAR) using the Ovation™ Device
It involves placement of the Ovation™ Device (a modular stent-graft device) for repair of the infrarenal AAA. The device seals the proximal aortic neck by using polymer to infuse the O-rings in order to achieve a customised seal without exerting outward radial force to maintain the seal.
The approximate duration of intervention is 2-3 hours which is similar to usual EVAR with other modular stent-graft systems.
The intervention will be performed by the principle investigator (PI). The PI is a Vascular Surgeon.
Intervention code [1] 300293 0
Treatment: Surgery
Comparator / control treatment
Historical control (EVAR using other modular stent graft systems)
Data from 01/2013 to 12/2014 in Prince of Wales Hospital
Control group
Historical

Outcomes
Primary outcome [1] 304757 0
Type Ia endoleak (assessed by the postoperative CT abdominal aortogram)
Timepoint [1] 304757 0
2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)
Secondary outcome [1] 343011 0
Number of All endoleaks (assessed by the postoperative CT abdominal aortogram)
Timepoint [1] 343011 0
2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)
Secondary outcome [2] 343012 0
Need for reintervention (assessed by the postoperative CT abdominal aortogram)
Timepoint [2] 343012 0
2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)
Secondary outcome [3] 343013 0
Number of participants with Aneurysm sac expansion (assessed by the postoperative CT abdominal aortogram)
Timepoint [3] 343013 0
2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)
Secondary outcome [4] 343014 0
Aneurysm sac expansion rate (assessed by the postoperative CT abdominal aortogram)
Timepoint [4] 343014 0
2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)
Secondary outcome [5] 343015 0
Aneurysm rupture (assessed by the postoperative CT abdominal aortogram and any emergency admission due to aneurysm rupture)
Timepoint [5] 343015 0
2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)
(Any emergency admission due to aneurysm rupture will be recorded at any time point during the 2 years duration)
Secondary outcome [6] 343016 0
Aneurysm-related mortality (assessed by hospital electronic records of any emergency admission and mortality)
Timepoint [6] 343016 0
2 years
(Any emergency admission or mortality due to aneurysm rupture will be recorded monthly during the 2 years duration)
Secondary outcome [7] 343017 0
Overall survival (assessed by hospital electronic records of any emergency admission and mortality)
Timepoint [7] 343017 0
2 years
(Any mortality will be recorded monthly during the 2 years duration)

Eligibility
Key inclusion criteria
1. Age of 18 years and above
2. Infrarenal abdominal aortic aneurysm indicated and feasible for endovascular repair:
a. Aortic aneurysms of 5cm and above
b. Aortic aneurysms with rapid increase in size (>5mm in 6 months or >10mm in 1 year)
c. Aneurysm anatomy otherwise suitable for EVAR
3. Hostile neck features:
a. Infrarenal angulation of greater than or equal to 60 degrees
b. Infrarenal neck length of >5 but <15mm
c. Reversed taper neck (gradual neck dilatation of >2mm within the first 10mm after the lowest renal artery)
d. greater than or equal to 50% circumferential proximal neck thrombus of greater than or equal to 2mm thick
e. greater than or equal to 50% circumferential calcified neck
f. Neck diameter greater than or equal to 28mm but less than or equal to 30mm
4. Consent to EVAR
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient unable to provide informed consent
2. Metastatic malignancy or other terminal medical condition
3. Limited life expectancy (<6 months)
4. Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment outside Australia
Country [1] 9578 0
Hong Kong
State/province [1] 9578 0

Funding & Sponsors
Funding source category [1] 298641 0
Hospital
Name [1] 298641 0
Prince of Wales Hospital
Country [1] 298641 0
Hong Kong
Primary sponsor type
Individual
Name
Yih Chun Ling Patricia
Address
Department of Surgery
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories
Country
Hong Kong
Secondary sponsor category [1] 297814 0
None
Name [1] 297814 0
Address [1] 297814 0
Country [1] 297814 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299601 0
Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee
Ethics committee address [1] 299601 0
8/F, Lui Che Woo Clinical Sciences Building
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories
Ethics committee country [1] 299601 0
Hong Kong
Date submitted for ethics approval [1] 299601 0
Approval date [1] 299601 0
16/01/2018
Ethics approval number [1] 299601 0
2017.485

Summary
Brief summary
Abdominal aortic aneurysm (AAA) is a severe and potentially life-threatening condition, with increasing incidence due to the aging population. Traditionally this has been treated by open surgery, which carries high perioperative risks of disability or death. With the advent of endovascular stenting (EVAR), which involves placing a stent-graft inside the aorta for exclusion of the anuerysm, for the treatment of this condition, the invasiveness and subsequently the risk has been greatly reduced. However the suitability of patients
for EVAR is limited by a narrow set of anatomical prerequisites, mostly which concern the neck region (the segment of aorta between renal arteries and the aneurysm) for satisfactory treatment. As a result patients suffering from AAA with hostile neck features are frequently excluded from the benefits of EVAR. Usage outside recommended anatomies has resulted in mixed results in different studies, while some studies finding that hostile neck features contribute to late complications after EVAR such as endoleak (persistent leakage of blood into the sac despite EVAR placement), and consequently, aneurysm sac enlargement and late rupture.
We propose that using the Ovation™ system which utilizes the O-ring sealing technology can provide a customized seal to the aortic neck region, thereby reducing endoleak and other complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80986 0
Dr Yih Chun Ling Patricia
Address 80986 0
Department of Surgery
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories
Country 80986 0
Hong Kong
Phone 80986 0
+852 35052211
Fax 80986 0
Email 80986 0
patricia@surgery.cuhk.edu.hk
Contact person for public queries
Name 80987 0
Dr Yih Chun Ling Patricia
Address 80987 0
Department of Surgery
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories
Country 80987 0
Hong Kong
Phone 80987 0
+852 35052211
Fax 80987 0
Email 80987 0
patricia@surgery.cuhk.edu.hk
Contact person for scientific queries
Name 80988 0
Dr Yih Chun Ling Patricia
Address 80988 0
Department of Surgery
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories
Country 80988 0
Hong Kong
Phone 80988 0
+852 35052211
Fax 80988 0
Email 80988 0
patricia@surgery.cuhk.edu.hk

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Results publications and other study-related documents

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