Nellix® Registry Study: EVAS-Global (EVAS-FORWARD 1)

March 2, 2022 updated by: Endologix

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

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.

Study Overview

Status

Active, not recruiting

Detailed Description

  1. Baseline: medical history, physical exams, CT image, bloodwork,
  2. Procedure: implantation information
  3. Discharge: Physical exam, bloodwork and adverse events, if any
  4. 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

Study Type

Observational

Enrollment (Actual)

300

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

      • Augsburg, Germany, 86156
        • Klinikum Augsburg Klinik für Gefäßchirurgie
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie
      • Essen, Germany, 45131
        • Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld
      • Nuernberg, Germany, 90471
        • Klinikum Sud Nuernberg, Dept of Vascular Surgery
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart Katharinenen Hospital
      • Riga, Latvia, LV-1002
        • Pauls Stadins Clinical University Hospital Riga
      • Luxembourg-Kirchberg, Luxembourg, L-2540
        • Hopital Kirchberg, Dept of Cardio-Vascular
      • Amsterdam, Netherlands, 1105AZ
        • Academisch Medisch Centrum Amsterdam, Department of Surgery
      • Arnhem, Netherlands, 6800 TA
        • Rijnstate Ziekenhuis, Vasculaire Centrum
      • Nieuwegein, Netherlands, 3435 CM
        • St Antonius Ziekenhuis, Dept of Vascular Surgery
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medical Centre, Dept of Vascular Surgery
      • Tilburg, Netherlands, 5022 GC
        • St Elisabeth Ziekenhuis, Dept of Vascular Surgery
      • Auckland, New Zealand, 1023
        • Auckland City Hospital Interventional Radiology
      • Hamar, Norway, 2326
        • Hospital Hamar
      • Orebro, Sweden
        • Orebro University Hospital, Department of General Surgery
      • Stockholm, Sweden, SE-171
        • Karolinska University Hospital
      • Cambridge, United Kingdom, CB20QQ
        • Addenbrooke's Hospital, Dept of Vascular Surgery
      • London, United Kingdom, SW170QT
        • St. George's Vascular Institute

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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Up to 300 patients diagnosed with AAA who are considered candidates for Endovascular Repair, who 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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immediate procedural technical success
Time Frame: Procedure
Number of subjects where immediate procedural technical success during procedure was noted
Procedure
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
Up to 30 days
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)
Up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Patency and Integrity
Time Frame: Up to 5 years
Number of subjects with device patency and integrity throughout the study.
Up to 5 years
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
Discharge
Distal Complications
Time Frame: 5 years
Incidence of distal thrombosis, embolization and iliac stenosis.
5 years

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Prof Andrew Holden, Auckland City Hospital
  • Principal Investigator: Dr. Michel Reijnen, MD, Rijnstate Hospital, Arnhem NL

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)

October 1, 2013

Primary Completion (Actual)

September 1, 2019

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • CP0010-Ver. 1

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.

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