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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02996396




Registration number
NCT02996396
Ethics application status
Date submitted
12/12/2016
Date registered
19/12/2016
Date last updated
19/12/2016

Titles & IDs
Public title
Nellix Registry Study: EVAS-Global
Scientific title
Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
Secondary ID [1] 0 0
CP0010 Ver. 2
Universal Trial Number (UTN)
Trial acronym
EVAS FORWARD 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm 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
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Nellix Endovascular Aneurysm Sealing System (Nellix®-System)

1 - Patients diagnosed with AAA who are considered candidates for Endovascular Repair and meet the study eligibility criteria and sign the Informed consent may be subsequently enrolled in the study.


Treatment: Devices: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.

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

Outcomes
Primary outcome [1] 0 0
Number of subjects with Immediate Procedural Technical Success - Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
Timepoint [1] 0 0
30 Days
Primary outcome [2] 0 0
Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs) - Safety endpoint is measured with the number of subjects who are reported freedome of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss > 1000mL at 30 Days post index procedure.
Timepoint [2] 0 0
30 Days

Eligibility
Key inclusion criteria
1. Male or female at least 18 years old

2. Subject has signed informed consent for data release

3. Subjects with with AAA and eligible for endovascular repair
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently participating in another study where primary endpoint has not been reached
yet

2. Known allergy to any of the device components

3. Pregnant (females of childbearing potential only)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
Multicenter, single arm, open label, registry study with consecutive, eligible patient
enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System
(EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as
per institutional standard of care thereafter through to 5 years (total follow-up commitment)
Trial website
https://clinicaltrials.gov/show/NCT02996396
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MBChB
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Frederick M Arbour
Address 0 0
Country 0 0
Phone 0 0
949-598-4667
Fax 0 0
Email 0 0
marbour@endologix.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02996396