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Trial registered on ANZCTR


Registration number
ACTRN12612000013864
Ethics application status
Approved
Date submitted
24/12/2011
Date registered
4/01/2012
Date last updated
19/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stent Trial for Coarctaion of the Aorta to evaluate the safety and efficacy of the Large Diameter Advanta V12 Covered Stent for treatment of native and recurrent coartation of the aorta with primary endpoint being a significant reduction in the gradient across the coarctation at 12 months
Scientific title
Stent Trial for Coarctaion of the Aorta to evaluate the safety and efficacy of the Large Diameter Advanta V12 Covered Stent for treatment of native and recurrent coartation of the aorta with primary endpoint being a significant reduction in the gradient across the coarctation at 12 months
Secondary ID [1] 273600 0
NCT00978952
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with a presence of native or recurrent coarctation of the aorta 285395 0
Condition category
Condition code
Cardiovascular 285575 285575 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients require transthoracic echocardiography and ECG to confirm eligibility. Eligible patients will undergo cardiac catheterisation to implant the stent into the thoracic aorta under general anaesthesia. Patients will undergo another echocardiogram at discharge, then at 6, 12, 24, 36, 48, and 60 months. A chest x-ray will be performed at 2 and 4 or 5 year follow up to evaluate the stent integrity.
Intervention code [1] 283885 0
Treatment: Devices
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286134 0
A significant reduction in the gradient across the coarctation as assessed pre stent versus immediately post stent and pre stent vs. 12 month follow-up in two values from the Doppler echocardiographic profile: DV (diastolic velocity in cm/sec) and DV/SV (diastolic velocity /systolic velocity atio).
Timepoint [1] 286134 0
12 months
Primary outcome [2] 286173 0
Morbidity rate (that is non-inferior to the surgery rate reported by Carr (The results of catheter based therapy compared with surgical repair of the adult aortic coarctation. J Am Coll Cardiol. 2006; 47: 1101-1107. ).
Timepoint [2] 286173 0
30 days
Secondary outcome [1] 295216 0
Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
Timepoint [1] 295216 0
At implant
Secondary outcome [2] 295300 0
Major Adverse Event and Major Adverse Vascular. Event.

Major adverse vascular events defined as:
Stroke or transient ischemic attack,
Aortic rupture,
Aortic dissection,
Aortic aneurysm requiring surgical intervention,
Inadvertent closure of significant aortic side branch,
Femoral Artery access rupture, thrombosis, clinically
apparent distal embolization,
Restenosis requiring reintervention,
Stent Fracture leading to loss of structural integrity,
Stent dislodgement, migration or embolization responsible for occluding any side branch or requiring surgical intervention.

Major adverse event defined as:
Death, stroke (hemorrhagic, non-hemorrhagic, or
unknown), significant embolic events causing end-
organ damage, (e.g. lower extremity ulceration or
gangrene),
Conversion to surgery due to procedure complication,
assessed by clinical evaluation and use of echocardiography (ultrasound) and radiological procedures (angiography) for confirmation.
Timepoint [2] 295300 0
12 months
Secondary outcome [3] 295301 0
An increase in the diameter of the coarctation after stent placement to greater than or equal to 80% of diameter of the transverse arch immediately distal to the left subclavian artery [isthmus] (CoA:DAo greater than or equal to 0.8) as measured by CT.
Timepoint [3] 295301 0
After the stenting procedure during index procedure and at 12 months.
Secondary outcome [4] 336139 0
No post procedural (12month) stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.
Timepoint [4] 336139 0
12 months

Eligibility
Key inclusion criteria
Inclusion Criteria: - Patients with a presence of native or recurrent coarctation of the aorta as confirmed by blood pressure gradient, 2D-echocardiography with Doppler or angiography. - Subject weighs a minimum of 30 kg. - The peak pressure gradient is greater than or eqaul to 20 mmHg systolic blood pressure across the coarctation site. - Vessels at access site can accept a minimum size of 9 French for a 12 mm balloon and 11 French for a 14 and 16 mm balloon. - Coarctation can be successfully crossed with a guide wire, sheath and device. - Diameter of transverse arch distal to left subclavian artery is between 9.5 mm and 20 mm in diameter. - Subject is able and willing to adhere to all required follow-up visits and testing. - Subject is able and willing to adhere to the required follow-up medication regimen.
Minimum age
0 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria: - The physician is not able to access the coarctation with standard techniques. - Presence of other thoracic aortic arterial lesions or aneurysms requiring treatment within 30 days of the implant procedure. - Length of coarctation is greater than 45 mm in length. - Connective tissue and genetic disorders, including William, Marfan, Turner, Noonan syndrome. - The coarctation has adjacent, acute thrombus. - The coarctation was previously treated with a stent. - Proximity of the coarctation to an important side branch resulting in crossing of the side branch with the Large Diameter Advanta V12 Covered Stent device (e.g. "jailing" of the branch vessel). - Subject has a tubular graft, interposition graft, stent graft at or near the coarctation site that would be interfere with delivery, positioning, expansion or stabilization of the Large Diameter Advanta V12 Covered Stent - Subject has contrast agent hypersensitivity that cannot be adequately premedicated, has a hypersensitivity to stainless steel, ePTFE or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications. - Bloodstream infection - Subject is pregnant or breastfeeding. - Subject has a co-morbid illness that may result in a life expectancy of less than 1 year. - The investigator deems the subject to be an inappropriate candidate for the study. - Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now approved product are not excluded by this criterion.

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective, multi-centre.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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
Recruitment outside Australia
Country [1] 4011 0
Israel
State/province [1] 4011 0
Country [2] 4012 0
Germany
State/province [2] 4012 0
Country [3] 4013 0
Italy
State/province [3] 4013 0
Country [4] 4014 0
United Kingdom
State/province [4] 4014 0
Country [5] 4015 0
Brazil
State/province [5] 4015 0
Country [6] 8999 0
Canada
State/province [6] 8999 0
Toronto

Funding & Sponsors
Funding source category [1] 284369 0
Commercial sector/Industry
Name [1] 284369 0
Atrium Medical Corporation
Address [1] 284369 0
40 Continental Blvd., Merrimack, NH, 03054
Country [1] 284369 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Atrium Medical Corporation
Address
5 Wentworth Drive
Hudson, NH, 03051
Country
United States of America
Secondary sponsor category [1] 283307 0
Commercial sector/Industry
Name [1] 283307 0
Atrium Australia - Pacific Rim Pty Ltd
Address [1] 283307 0
Level 6, 579 Harris Street
Ultimo NSW 2007
Country [1] 283307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286330 0
The Children's Hospital at Westmead Ethics Committee
Ethics committee address [1] 286330 0
Locked Bag 4001
Westmead NSW 2145
Ethics committee country [1] 286330 0
Australia
Date submitted for ethics approval [1] 286330 0
01/07/2009
Approval date [1] 286330 0
13/11/2009
Ethics approval number [1] 286330 0
09/CHW/130

Summary
Brief summary
The primary objective is to evaluate the safety and efficacy of
the Large Diameter Advanta V12 Covered Stent for
treatment of native and recurrent aortic coarctation of the aorta in selected children and adolescents.
Trial website
http://www.heartcentreforchildren.com.au/tabid/370/Default.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33529 0
Dr Philip Roberts
Address 33529 0
Heart Centre for Children the children's hospital at Westmead Hawkesbury Road Westmead NSW 2145
Country 33529 0
Australia
Phone 33529 0
+612 9845 2345
Fax 33529 0
Email 33529 0
andrew.cole@health.nsw.gov.au
Contact person for public queries
Name 16776 0
Mr Andrew Cole
Address 16776 0
Heart Centre for Children
the children's hospital at Westmead
Hawkesbury Road
Westmead NSW 2145
Country 16776 0
Australia
Phone 16776 0
+612 9845 2345
Fax 16776 0
Email 16776 0
andrew.cole@health.nsw.gov.au
Contact person for scientific queries
Name 7704 0
Mr Andrew Cole
Address 7704 0
Heart Centre for Children
the children's hospital at Westmead
Hawkesbury Road
Westmead NSW 2145
Country 7704 0
Australia
Phone 7704 0
+612 9845 2345
Fax 7704 0
Email 7704 0
andrew.cole@health.nsw.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary