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Completed

NCT Number: NCT02996396

Nellix Registry Study: EVAS-Global

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)

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Augsburg Klinik für Gefäßchirurgie, Augsburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female at least 18 years old
  • Subject has signed informed consent for data release
  • Subjects with with AAA and eligible for endovascular repair

Exclusion criteria

  • Currently participating in another study where primary endpoint has not been reached yet
  • Known allergy to any of the device components
  • Pregnant (females of childbearing potential only)

Treatment and study plan

Nellix Endovascular Aneurysm Sealing System (Nellix®-System)

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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. 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.

  6. Number of subjects with Clinically significant migration

    Time frame: 5 years

    The number of patients with clinically significant migration will be summarized descriptively.

  7. 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.

  8. Number of incidence with Secondary endovascular procedures

    Time frame: 5 years

    The overall secondary procedure incidence and the individual component incidence will be provided.

Other outcomes

  1. 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.

  2. Number of incidence with Distal Complications

    Time frame: 5 years

    The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Official study title

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

Acronym: EVAS FORWARD 2

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Dec 19, 2016
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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