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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00978952




Trial ID
NCT00978952
Ethics application status
Date submitted
14/09/2009
Date registered
16/09/2009
Date last updated
29/06/2017

Titles & IDs
Public title
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Scientific title
Large Diameter Advanta™ V12 Covered Stent Trial for Coarctation of the Aorta
Secondary ID [1] 0 0
803
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coarctation of the Aorta 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Large Diameter Advanta™ V12 Covered Stent

Experimental: Investigational Group - Use of Large Diameter Advanta™ V12 Covered Stent.


Treatment: Devices: Large Diameter Advanta™ V12 Covered Stent
Stent placement

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy - The mean difference between Diastolic Velocity (DV)/Systolic Velocity(SV) pre and post procedure (i.e. pre procedure DV/SV - post procedure DV/SV) minus the difference between 12 month and post procedure (i.e. 12 month DV/SV - post procedure DV/SV).
Timepoint [1] 0 0
12 month
Primary outcome [2] 0 0
Primary Safety - 30 day morbidity rate of Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Timepoint [2] 0 0
30 days of procedure
Secondary outcome [1] 0 0
Secondary Safety - Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system.
Timepoint [1] 0 0
procedural (time zero)
Secondary outcome [2] 0 0
Secondary Safety - No post procedural stent migration, where migration is defined as displacement of the stent >20mm from an established anatomical landmark verified during deployment.
Timepoint [2] 0 0
12 month
Secondary outcome [3] 0 0
Secondary Safety - Major Adverse Events (MAE)and Major Adverse Vascular Events (MAVE)
Timepoint [3] 0 0
12 months

Eligibility
Key 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 =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
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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, expanded polytetrafluoroethylene (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
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Sao Paulo
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Frankfurt
Country [5] 0 0
Germany
State/province [5] 0 0
Sankt Augustin
Country [6] 0 0
Israel
State/province [6] 0 0
Petach Tikva
Country [7] 0 0
Italy
State/province [7] 0 0
Milan
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atrium Medical Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed as a prospective, multicenter, non-randomized, single arm study to
assess the safety and effectiveness of the Large Diameter Advanta™ V12 Covered Stent for
stent implantation in coarctations of the aorta.
Trial website
https://clinicaltrials.gov/show/NCT00978952
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elchanan Bruckheimer, MD
Address 0 0
Schneider Children's Medical Center, Israel
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries