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Nellix® Registry Study: EVAS-Global

NCT02018744 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Safety and Performance of the Nellix Endovascular Sealing System

Sponsors & Collaborators

  • Endologix

    lead INDUSTRY

Principal Investigators

  • Prof Andrew Holden, MBChB · Auckland City Hospital

  • Dr. Michel Reijnen, MD · Rijnstate Hospital, Arnhem NL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-09-30
Completion
2022-07-07

Countries

  • Germany
  • Latvia
  • Luxembourg
  • Netherlands
  • New Zealand
  • Norway
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02018744 on ClinicalTrials.gov