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Completed

NCT Number: NCT02018744

Nellix® Registry Study: EVAS-Global

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.

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Key information

Conditions

Safety and Performance of the Nellix Endovascular Sealing System

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.

About this study

  • Baseline: medical history, physical exams, CT image, bloodwork,
  • Procedure: implantation information
  • Discharge: Physical exam, bloodwork and adverse events, if any
  • Follow-up according to institutional standard through to 5 years including Physical exam, CT image or standard of care imaging eg Doppler Ultrasound, bloodwork and adverse events, if any

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 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

Primary outcomes

  1. Immediate procedural technical success

    Time frame: Procedure

    Number of subjects where immediate procedural technical success during procedure was noted

  2. Peri-operative Safety Parameters

    Time frame: Up to 30 days

    Number of subjects with procedural Blood loss >1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke

  3. Clinical outcome

    Time frame: Up to 5 years

    Number of subjects with Aneurysm rupture, Conversion to open surgical repair, Endoleak of any type, Clinically significant migration, Aneurysm enlargement through to five years, Secondary endovascular procedures of any type through to five years, Secondary endovascular procedures for (resolution of Endoleak of any type; Device occlusion (due to thrombus or other causes); Device migration AAA sac expansion (>5mm diameter increase); Device defect)

Other outcomes

  1. Device Patency and Integrity

    Time frame: Up to 5 years

    Number of subjects with device patency and integrity throughout the study.

  2. In-hospital evaluations

    Time frame: Discharge

    Evaluation of total amount of polymer fill, total endovascular time, anaesthesia time, fluoroscopy time, contrast volume used, total procedure time, estimated blood loss, incidence of transfusion, time in ICU, time to hospital discharge

  3. Distal Complications

    Time frame: 5 years

    Incidence of distal thrombosis, embolization and iliac stenosis.

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Official study title

Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair

Acronym: EVAS-FORWARD 1

Important dates

Study start
2013
Primary completion
2019
Study completion
2022
First posted
Dec 23, 2013
Registry last updated
May 8, 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.