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Nellix Registry Study: EVAS-Global

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Disease Information

Descriptive Information
Brief Title † Nellix Registry Study: EVAS-Global
Official Title † Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
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)
Detailed Description
Study Phase N/A
Study Type † Observational [Patient Registry]
Study Design † Observational Model: Cohort, Time Perspective: Prospective
Primary Outcome Measure † Number of subjects with Immediate Procedural Technical Success
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm
Intervention † DeviceNellix Endovascular Aneurysm Sealing System (Nellix®-System)
Study Arms / Comparison Groups 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.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Device
Estimated Enrollment † 300
Start Date † November 2016
Completion Date October 2023
Primary Completion Date December 2022
Eligibility Criteria † 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 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)
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Frederick M Arbour, 949-598-4667, marbour@endologix.com
Location Countries † New Zealand
Administrative Information
NCT ID † NCT02996396
Organization ID CP0010 Ver. 2
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Endologix
Collaborators ††
Investigators † Principal Investigator: Andrew Holden, MBChB, Auckland City Hospital
Information Provided By
Verification Date December 2016
First Received Date † December 12, 2016
Last Updated Date December 14, 2016
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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