Safety and Performance of the Nellix Endovascular Sealing SystemEVAS-FORWARD 1NCT02018744
Nellix® Registry Study: EVAS-Global
An observational study of Safety and Performance of the Nellix Endovascular Sealing System, run by Endologix at 19 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Safety and Performance of the Nellix Endovascular Sealing System
- How many people
- 300 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Oct 2013to 7 Jul 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Male or female at least 18 years old
- Subject has signed informed consent for data release
- Subjects with AAA and eligible for endovascular repair
Who cannot join
- 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)
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Germany6 sites
Klinikum Augsburg Klinik für Gefäßchirurgie
Augsburg, 86156
Universitätsklinikum Düsseldorf Klinik für Gefäß- und Endovaskularchirurgie
Düsseldorf, 40225
Alfried Krupp Krankenhaus Ruttenscheid, Vascular Centre
Essen, 45131
Universitätsklinikum Heidelberg Klinik für Gefäßchirurgie Im Neuenheimer Feld
Heidelberg, 69120
Klinikum Sud Nuernberg, Dept of Vascular Surgery
Nuremberg, 90471
Klinikum Stuttgart Katharinenen Hospital
Stuttgart, 70174
Netherlands5 sites
Academisch Medisch Centrum Amsterdam, Department of Surgery
Amsterdam, 1105AZ
Rijnstate Ziekenhuis, Vasculaire Centrum
Arnhem, 6800 TA
St Antonius Ziekenhuis, Dept of Vascular Surgery
Nieuwegein, 3435 CM
Erasmus Medical Centre, Dept of Vascular Surgery
Rotterdam, 3015 CE
St Elisabeth Ziekenhuis, Dept of Vascular Surgery
Tilburg, 5022 GC
Sweden2 sites
Orebro University Hospital, Department of General Surgery
Örebro
Karolinska University Hospital
Stockholm, SE-171
United Kingdom2 sites
Addenbrooke's Hospital, Dept of Vascular Surgery
Cambridge, CB20QQ
St. George's Vascular Institute
London, SW170QT
Luxembourg1 site
Hopital Kirchberg, Dept of Cardio-Vascular
Luxembourg-Kirchberg, L-2540
New Zealand1 site
Auckland City Hospital Interventional Radiology
Auckland, 1023
About this study
Official title: 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.
Read the detailed description
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nellix System | Nellix 3SQ+ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate procedural technical success
Number of subjects where immediate procedural technical success during procedure was noted
Measured: Procedure
Peri-operative Safety Parameters
Number of subjects with procedural Blood loss >1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke
Measured: Up to 30 days
Clinical outcome
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)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2019
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Performance of the Nellix Endovascular Sealing SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Andrew Holden, MBChB, Principal investigator, Auckland City HospitalDr. Michel Reijnen, MD, Principal investigator, Rijnstate Hospital, Arnhem NL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018744
- Sponsor's protocol ID
- CP0010-Ver. 1
- Acronym
- EVAS-FORWARD 1
- Status last verified
- May 2026
- First submitted
- 18 Nov 2013
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair
- ClinicalTrials.gov ID
- NCT02018744
- Acronym / sponsor ID
- EVAS-FORWARD 1 / CP0010-Ver. 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nellix System | – | –Nellix 3SQ+ device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Male or female at least 18 years old
- Subject has signed informed consent for data release
- Subjects with AAA and eligible for endovascular repair
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immediate procedural technical success
Time frame: Procedure
Number of subjects where immediate procedural technical success during procedure was noted
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Andrew Holden, MBChB principal investigator
Auckland City Hospital
Dr. Michel Reijnen, MD principal investigator
Rijnstate Hospital, Arnhem NL
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety and Performance of the Nellix Endovascular Sealing System, run by Endologix at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Netherlands, Sweden, United Kingdom, Latvia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate procedural technical success (time frame: Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.