Abdominal Aortic AneurysmEVAS FORWARD 2NCT02996396
Nellix Registry Study: EVAS-Global
An observational study of Abdominal Aortic Aneurysm, run by Endologix at 10 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Nov 2016to 27 Feb 2024
- How long will I take part?
- 60 Months
- 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: 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.
Who may be able to join
- 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
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
10 sites in 4 countries.
10 sites in 4 countries
Germany5 sites
Klinikum Augsburg Klinik für Gefäßchirurgie
Augsburg, 86156
St. Marien Hospital Bonn
Bonn, 53115
University Hospital Koeln
Cologne, 50937
University Hospital Heidelberg
Heidelberg, 69120
TUM Munich
Munich, 80333
Netherlands2 sites
Rijnstate Hospital
Arnhem, 90
St Elisabeth Ziekenhuis, Dept of Vascular Surgery
Tilburg, 5022 GC
Spain2 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Universitario y Politécnico de La Fe
Valencia, 46026
About this study
Official title: 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)
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
- Keywords
- AAA, Aortoiliac Aneurysm
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nellix Endovascular Aneurysm Sealing System (Nellix®-System)Device
Also called Nellix EVAS FORWARD 2
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Immediate Procedural Technical Success
Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
Measured: 30 Days
Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)
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.
Measured: 30 Days
Number of subjects with Aneurysm rupture
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).
Measured: 5 years
Number of subjects with Conversion to open surgical repair
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).
Measured: 5 years
Number of subjects with Endoleak of any type
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.
Measured: 5 years
Number of subjects with Clinically significant migration
The number of patients with clinically significant migration will be summarized descriptively.
Measured: 5 years
Number of subjects with Aneurysm enlargement
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.
Measured: 5 years
Number of incidence with Secondary endovascular procedures
The overall secondary procedure incidence and the individual component incidence will be provided.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion25 Apr 2023
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies 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
- 48 participants (actual)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MBChB, Principal investigator, Auckland City HospitalMichel Reijnen, MD, Principal investigator, Rijnstate, Arnhem, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996396
- Sponsor's protocol ID
- CP0010 Ver. 2
- Acronym
- EVAS FORWARD 2
- Status last verified
- Jun 2026
- First submitted
- 12 Dec 2016
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
- ClinicalTrials.gov ID
- NCT02996396
- Acronym / sponsor ID
- EVAS FORWARD 2 / CP0010 Ver. 2
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- AAA, Aortoiliac Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 19 Dec 2016 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nellix Endovascular Aneurysm Sealing System (Nellix®-System)Also: Nellix EVAS FORWARD 2The 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. | Device | 1 |
Primary outcome
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.
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.
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).
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).
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.
Number of subjects with Clinically significant migration
Time frame: 5 years
The number of patients with clinically significant migration will be summarized descriptively.
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.
Number of incidence with Secondary endovascular procedures
Time frame: 5 years
The overall secondary procedure incidence and the individual component incidence will be provided.
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 17 Jun 2026.
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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.
Andrew Holden, MBChB principal investigator
Auckland City Hospital
Michel Reijnen, MD principal investigator
Rijnstate, Arnhem, the Netherlands
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Endologix at 10 sites in 4 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Netherlands, Spain, New Zealand. 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?
Number of subjects with Immediate Procedural Technical Success (time frame: 30 Days). The study lists 8 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 17 Jun 2026.