Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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/NCT02996396




Registration number
NCT02996396
Ethics application status
Date submitted
12/12/2016
Date registered
19/12/2016
Date last updated
7/06/2022

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
Assessment method [1] 0 0
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)
Assessment method [2] 0 0
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
Primary outcome [3] 0 0
Number of subjects with Aneurysm rupture
Assessment method [3] 0 0
The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Timepoint [3] 0 0
5 years
Primary outcome [4] 0 0
Number of subjects with Conversion to open surgical repair
Assessment method [4] 0 0
The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Timepoint [4] 0 0
5 years
Primary outcome [5] 0 0
Number of subjects with Endoleak of any type
Assessment method [5] 0 0
The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized.
Timepoint [5] 0 0
5 years
Primary outcome [6] 0 0
Number of subjects with Clinically significant migration
Assessment method [6] 0 0
The number of patients with clinically significant migration will be summarized descriptively.
Timepoint [6] 0 0
5 years
Primary outcome [7] 0 0
Number of subjects with Aneurysm enlargement
Assessment method [7] 0 0
The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement.
Timepoint [7] 0 0
5 years
Primary outcome [8] 0 0
Number of incidence with Secondary endovascular procedures
Assessment method [8] 0 0
The overall secondary procedure incidence and the individual component incidence will be provided.
Timepoint [8] 0 0
5 years

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
Sex
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
Accrual to date
Final
300
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Augsburg
Country [2] 0 0
Germany
State/province [2] 0 0
Bonn
Country [3] 0 0
Germany
State/province [3] 0 0
Heidelberg
Country [4] 0 0
Germany
State/province [4] 0 0
Koeln
Country [5] 0 0
Germany
State/province [5] 0 0
Munich
Country [6] 0 0
Netherlands
State/province [6] 0 0
Arnhem
Country [7] 0 0
Netherlands
State/province [7] 0 0
Tilburg
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
Spain
State/province [9] 0 0
A Coruña
Country [10] 0 0
Spain
State/province [10] 0 0
Valencia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MBChB
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02996396