Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02048514




Registration number
NCT02048514
Ethics application status
Date submitted
27/01/2014
Date registered
29/01/2014
Date last updated
9/03/2021

Titles & IDs
Public title
The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
Scientific title
The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
Secondary ID [1] 0 0
N09-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Nellix Aneurysm Sealing - The Nellix® EndoVascular Aneurysm Sealing System
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety- Number of Major Adverse Events
Timepoint [1] 0 0
30 day
Primary outcome [2] 0 0
Device Performance
Timepoint [2] 0 0
30 days
Secondary outcome [1] 0 0
All Cause Mortality
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion criteria
* At least 18 years of age
* Informed consent form understood and signed and patient agrees to all follow-up visits
* Is able and willing to comply with clinical follow-up requirements for one year
* Is able and willing to undergo Contrast-Enhanced Spiral CT scans
* Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;

1. aneurysm = 4.5 cm in diameter, or
2. aneurysm is twice the diameter of the normal infrarenal aorta, or
3. aneurysm is growing at a rate of = 10 % per year
* Non-aneurysmal aortic neck length = 5mm below the most inferior renal artery
* Proximal aortic neck diameter between 16 and 36mm
* Aortic neck angulation to the sac = 60
* Common iliac artery diameter 8 to 35mm bilaterally
* Aneurysm blood lumen diameter = 60mm
* Iliac and femoral arteries suitable for endovascular access with the Nellix System
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Life expectancy = 1 year
* Dissecting, ruptured, or leaking aneurysm (blood outside the aorta), has sustained recent trauma, is symptomatic, or is non-degenerative
* Aneurysm is thoraco-abdominal, suprarenal and/or mycotic
* Thoracic aneurysm = 4.5cm in diameter
* AAA requires treatment that would result in bilateral occlusion of the internal iliac arteries
* Presence of mural thrombus > 50% circumferentially in aortic neck
* Iliac aneurysm blood lumen diameter > 35mm
* Active infection, vasculitis, or systemic connective tissue disease (e.g., Rheumatoid arthritis, scleroderma, Marfan's syndrome, Ehlers-Danlos disease) at time of procedure
* History of prior treatment of abdominal aortic or iliac artery aneurysm disease
* Femoral or iliac artery occlusive disease such that device delivery is not possible
* Vascular access for delivery of device requires placement of vascular conduit or is through an established vascular graft
* Receiving dialysis
* History of hypercoagulability
* Allergy to IV contrast
* Serum creatinine level >2.0 mg/dL (or equivalent)
* Patient is pregnant or nursing
* Patient is currently enrolled in an investigational drug or device trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Colombia
State/province [1] 0 0
Cali
Country [2] 0 0
Latvia
State/province [2] 0 0
Riga
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Venezuela
State/province [4] 0 0
Caracas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endologix
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.
Trial website
https://clinicaltrials.gov/study/NCT02048514
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02048514