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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 March 2022 |
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Main ID: |
NCT02018744 |
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Date of registration:
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18/11/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Nellix® Registry Study: EVAS-Global
EVAS-FORWARD 1 |
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Scientific title:
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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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Date of first enrolment:
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October 2013 |
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Target sample size:
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300 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02018744 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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France
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Germany
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Latvia
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Luxembourg
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Netherlands
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New Zealand
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Norway
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Spain
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Sweden
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Switzerland
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United Kingdom
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Contacts
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Name:
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Prof Andrew Holden |
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Address:
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Telephone:
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Email:
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Affiliation:
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Auckland City Hospital |
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Name:
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Dr. Michel Reijnen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rijnstate Hospital, Arnhem NL |
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Key inclusion & exclusion criteria
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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
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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Safety and Performance of the Nellix Endovascular Sealing System
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Primary Outcome(s)
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Peri-operative Safety Parameters
[Time Frame: Up to 30 days]
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Clinical outcome
[Time Frame: Up to 5 years]
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Immediate procedural technical success
[Time Frame: Procedure]
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Secondary ID(s)
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CP0010-Ver. 1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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