Nellix Registry Study: EVAS-Global (EVAS FORWARD 2)

June 15, 2026 updated by: Endologix

Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg Klinik für Gefäßchirurgie
      • Bonn, Germany, 53115
        • St. Marien Hospital Bonn
      • Cologne, Germany, 50937
        • University Hospital Koeln
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
      • Munich, Germany, 80333
        • TUM Munich
  • Netherlands
      • Arnhem, Netherlands, 90
        • Rijnstate Hospital
      • Tilburg, Netherlands, 5022 GC
        • St Elisabeth Ziekenhuis, Dept of Vascular Surgery
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
  • Spain
      • A Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña
      • Valencia, Spain, 46026
        • Hospital Universitario y Politécnico de La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other Names:
  • Nellix EVAS FORWARD 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with Immediate Procedural Technical Success
Time Frame: 30 Days
Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
30 Days
Number of subjects with Aneurysm rupture
Time Frame: 5 years
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).
5 years
Number of subjects with Conversion to open surgical repair
Time Frame: 5 years
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).
5 years
Number of subjects with Endoleak of any type
Time Frame: 5 years
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.
5 years
Number of subjects with Clinically significant migration
Time Frame: 5 years
The number of patients with clinically significant migration will be summarized descriptively.
5 years
Number of subjects with Aneurysm enlargement
Time Frame: 5 years
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.
5 years
Number of incidence with Secondary endovascular procedures
Time Frame: 5 years
The overall secondary procedure incidence and the individual component incidence will be provided.
5 years
Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)
Time Frame: 30 Days
Safety endpoint is measured with the number of subjects who are reported freedom 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.
30 Days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects with incidence of device patency and integrity
Time Frame: 5 years
Device patency and integrity will be measured by the number and proportion of patients at 30 days, 6 months, and 1 year to 5 years including Stent Kinking, Lumen Occlusion, and Stent Fracture.
5 years
Number of incidence with Distal Complications
Time Frame: 5 years
The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endologix

Investigators

  • Principal Investigator: Andrew Holden, MBChB, Auckland City Hospital
  • Principal Investigator: Michel Reijnen, MD, Rijnstate, Arnhem, the Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

April 25, 2023

Study Completion (Actual)

February 27, 2024

Study Registration Dates

First Submitted

December 12, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimated)

December 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP0010 Ver. 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe