ANZCTR - Registration

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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Abdominal aortic aneurysm

Condition category

Condition code

Cardiovascular

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]

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]

Type Ia endoleak (assessed by the postoperative CT abdominal aortogram)

Timepoint [1]

2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)

Secondary outcome [1]

Number of All endoleaks (assessed by the postoperative CT abdominal aortogram)

Timepoint [1]

2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)

Secondary outcome [2]

Need for reintervention (assessed by the postoperative CT abdominal aortogram)

Timepoint [2]

2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)

Secondary outcome [3]

Number of participants with Aneurysm sac expansion (assessed by the postoperative CT abdominal aortogram)

Timepoint [3]

2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)

Secondary outcome [4]

Aneurysm sac expansion rate (assessed by the postoperative CT abdominal aortogram)

Timepoint [4]

2 years
(CT abdominal aortogram will be performed at 1 month, 6 months, 12 months and 24 months after the intervention)

Secondary outcome [5]

Aneurysm rupture (assessed by the postoperative CT abdominal aortogram and any emergency admission due to aneurysm rupture)

Timepoint [5]

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]

Aneurysm-related mortality (assessed by hospital electronic records of any emergency admission and mortality)

Timepoint [6]

2 years
(Any emergency admission or mortality due to aneurysm rupture will be recorded monthly during the 2 years duration)

Secondary outcome [7]

Overall survival (assessed by hospital electronic records of any emergency admission and mortality)

Timepoint [7]

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]

Hong Kong

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Prince of Wales Hospital

Address [1]

30-32 Ngan Shing Street
Shatin, New Territories
Hong Kong

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Ethics committee address [1]

8/F, Lui Che Woo Clinical Sciences Building
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories

Ethics committee country [1]

Hong Kong

Date submitted for ethics approval [1]

Approval date [1]

16/01/2018

Ethics approval number [1]

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

Dr Yih Chun Ling Patricia

Address

Department of Surgery
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories

Country

Hong Kong

Phone

+852 35052211

Fax

Email

[email protected]

Contact person for public queries

Name

Yih Chun Ling Patricia

Address

Department of Surgery
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories

Country

Hong Kong

Phone

+852 35052211

Fax

Email

[email protected]

Contact person for scientific queries

Name

Yih Chun Ling Patricia

Address

Department of Surgery
Prince of Wales Hospital
30-32 Ngan Shing Street
Shatin, New Territories

Country

Hong Kong

Phone

+852 35052211

Fax

Email

[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.