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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
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Scientific title
Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
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Secondary ID [1]
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CP0010 Ver. 2
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Universal Trial Number (UTN)
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Trial acronym
EVAS FORWARD 2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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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
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.
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Intervention code [1]
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Treatment: Devices
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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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Number of subjects with Immediate Procedural Technical Success
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Assessment method [1]
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Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
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Timepoint [1]
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30 Days
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Primary outcome [2]
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Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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30 Days
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Primary outcome [3]
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Number of subjects with Aneurysm rupture
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Assessment method [3]
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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).
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Timepoint [3]
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5 years
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Primary outcome [4]
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Number of subjects with Conversion to open surgical repair
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Assessment method [4]
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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).
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Timepoint [4]
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5 years
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Primary outcome [5]
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Number of subjects with Endoleak of any type
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Assessment method [5]
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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.
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Timepoint [5]
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5 years
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Primary outcome [6]
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Number of subjects with Clinically significant migration
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Assessment method [6]
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The number of patients with clinically significant migration will be summarized descriptively.
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Timepoint [6]
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5 years
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Primary outcome [7]
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Number of subjects with Aneurysm enlargement
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Assessment method [7]
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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.
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Timepoint [7]
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5 years
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Primary outcome [8]
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Number of incidence with Secondary endovascular procedures
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Assessment method [8]
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The overall secondary procedure incidence and the individual component incidence will be provided.
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Timepoint [8]
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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 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
Active, not recruiting
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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
1/11/2016
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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
1/11/2024
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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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Country [2]
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Germany
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State/province [2]
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Bonn
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Germany
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State/province [3]
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Heidelberg
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Country [4]
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Germany
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State/province [4]
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Koeln
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Country [5]
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Germany
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State/province [5]
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Munich
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Country [6]
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Netherlands
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State/province [6]
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Arnhem
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Country [7]
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Netherlands
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State/province [7]
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Tilburg
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Country [8]
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New Zealand
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State/province [8]
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Auckland
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Country [9]
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Spain
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State/province [9]
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A Coruña
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Country [10]
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Spain
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State/province [10]
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Valencia
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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
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)
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Trial website
https://clinicaltrials.gov/study/NCT02996396
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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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Andrew Holden, MBChB
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Address
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Auckland City Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/NCT02996396
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