MedTrace Logo

Nellix Registry Study: EVAS-Global

NCT02996396 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2022-06-07

No results posted yet for this study

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)

Conditions

  • Abdominal Aortic Aneurysm

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Endologix

    lead INDUSTRY

Principal Investigators

  • Andrew Holden, MBChB · Auckland City Hospital

  • Michel Reijnen, MD · Rijnstate, Arnhem, the Netherlands

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2023-11-21
Completion
2024-11-30

Countries

  • Germany
  • Netherlands
  • New Zealand
  • Spain

Study Locations

More Related Trials

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 NCT02996396 on ClinicalTrials.gov