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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02018744




Registration number
NCT02018744
Ethics application status
Date submitted
18/11/2013
Date registered
23/12/2013
Date last updated
30/07/2018

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

Health condition
Health condition(s) or problem(s) studied:
Safety and Performance of the Nellix Endovascular Sealing System 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Immediate procedural technical success - Number of subjects where immediate procedural technical success during procedure was noted
Timepoint [1] 0 0
Procedure
Primary outcome [2] 0 0
Peri-operative Safety Parameters - Number of subjects with procedural Blood loss >1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke
Timepoint [2] 0 0
Up to 30 days
Primary outcome [3] 0 0
Clinical outcome - Number of subjects with Aneurysm rupture, Conversion to open surgical repair, Endoleak of any type, Clinically significant migration, Aneurysm enlargement through to five years, Secondary endovascular procedures of any type through to five years, Secondary endovascular procedures for (resolution of Endoleak of any type; Device occlusion (due to thrombus or other causes); Device migration AAA sac expansion (>5mm diameter increase); Device defect)
Timepoint [3] 0 0
Up to 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 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
Active, not 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
Germany
State/province [1] 0 0
Augsburg
Country [2] 0 0
Germany
State/province [2] 0 0
Düsseldorf
Country [3] 0 0
Germany
State/province [3] 0 0
Essen
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Germany
State/province [5] 0 0
Nuernberg
Country [6] 0 0
Latvia
State/province [6] 0 0
Riga
Country [7] 0 0
Luxembourg
State/province [7] 0 0
Luxembourg-Kirchberg
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
Netherlands
State/province [9] 0 0
Arnhem
Country [10] 0 0
Netherlands
State/province [10] 0 0
Nieuwegein
Country [11] 0 0
Netherlands
State/province [11] 0 0
Rotterdam
Country [12] 0 0
Netherlands
State/province [12] 0 0
Tilburg
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland
Country [14] 0 0
Norway
State/province [14] 0 0
Hamar
Country [15] 0 0
Sweden
State/province [15] 0 0
Orebro
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Cambridge
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
This registry has been designed as a multicenter, single arm, open label, post-market
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 up to discharge discharge, and as per institutional standard of care
thereafter through to 5 years (total follow-up commitment). This registry of the Nellix
System, which has received the market authorization of the European Union (Conformité
Européenne, CE-certification) in a "real world" patient population treated in a multicenter
setting will provide an assessment of the generalizability of the approach and System.

Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered
candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the
study.
Trial website
https://clinicaltrials.gov/show/NCT02018744
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Prof Andrew Holden
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications