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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02018744
Registration number
NCT02018744
Ethics application status
Date submitted
18/11/2013
Date registered
23/12/2013
Date last updated
3/03/2022
Titles & IDs
Public title
Nellix® Registry Study: EVAS-Global
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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
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Secondary ID [1]
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CP0010-Ver. 1
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Universal Trial Number (UTN)
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Trial acronym
EVAS-FORWARD 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Safety and Performance of the Nellix Endovascular Sealing System
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Condition category
Condition code
Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Immediate procedural technical success
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Assessment method [1]
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Number of subjects where immediate procedural technical success during procedure was noted
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Timepoint [1]
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Procedure
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Primary outcome [2]
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Peri-operative Safety Parameters
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Assessment method [2]
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Number of subjects with procedural Blood loss \>1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke
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Timepoint [2]
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Up to 30 days
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Primary outcome [3]
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Clinical outcome
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Assessment method [3]
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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)
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Timepoint [3]
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Up to 5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2022
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Actual
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Sample size
Target
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Accrual to date
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Final
300
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Augsburg
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Germany
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Düsseldorf
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Germany
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Essen
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Germany
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Heidelberg
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Germany
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Nuernberg
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Germany
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Stuttgart
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Latvia
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Riga
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Luxembourg
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Luxembourg-Kirchberg
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Nieuwegein
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Netherlands
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Rotterdam
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Netherlands
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State/province [13]
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Tilburg
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New Zealand
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Auckland
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Norway
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Hamar
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Sweden
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Orebro
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Sweden
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Stockholm
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United Kingdom
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Cambridge
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Country [19]
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United Kingdom
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State/province [19]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Endologix
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02018744
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Andrew Holden
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Address
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Auckland City Hospital
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Fax
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Email
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Contact person for public queries
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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/NCT02018744
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