Abdominal Aortic Aneurysm (AAA)EVAS1NCT01726257

Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System

A study testing Nellix System in people with Abdominal Aortic Aneurysm (AAA), run by Endologix at 30 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aortic Aneurysm (AAA)
What is being tested?: Nellix System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 333 participants
Where: 30 sitesin 4 countries
Study dates: Dec 2013to Dec 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Male or female at least 18 years old;
Informed consent understood and signed;
Patient agrees to all follow-up visits;
Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
Anatomic eligibility for the Nellix System per the instructions for use:
Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);

Show all 11Show fewer

Aneurysm blood lumen diameter ≤60mm;
Most caudal renal artery to aortoiliac bifurcation length ≥100mm;
Proximal non-aneurysmal aortic neck: length ≥10mm; lumen diameter 18 to 32mm; angle ≤60° to the aneurysm sac;
Common iliac artery lumen diameter between 9 and 35mm with blood lumen diameter ≤35mm;
Ability to preserve at least one hypogastric artery.

Who cannot join

Life expectancy <2 years;
Psychiatric or other condition that may interfere with the study;
Participating in enrollment of another clinical study
Known allergy to device any device component;
Coagulopathy or uncontrolled bleeding disorder;
Ruptured, leaking or mycotic aneurysm;

Show all 13Show fewer

Serum creatinine level >2.0mg/dL;
CVA or MI within three months of enrollment/treatment;
Aneurysmal disease of the descending thoracic aorta;
Clinically significant infrarenal mural thrombus (>5mm thickness over >50% circumference);
Connective tissue diseases (e.g., Marfan Syndrome)
Unsuitable vascular anatomy;
Pregnant (females of childbearing potential only).

Trial locations and contacts

30 sites in 4 countries.

Country

City, postcode or hospital

30 sites in 4 countries

United States27 sites

St. Vincent Heart and Vascular Center of Montana
Billings, Montana, 59101
St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Cooper Hospital
Camden, New Jersey, 08102
Carolinas Health Care
Charlotte, North Carolina, 28203
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio Health Research Institute
Columbus, Ohio, 43214
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Spectrum Health
Grand Rapids, Michigan, 49546
St. Luke's Medical Center
Houston, Texas, 77030
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46077
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Baptist Hospital of Miami
Miami, Florida, 33176
Froedtert Memorial Lutheran Hospital (Medical College of Wisconsin)
Milwaukee, Wisconsin, 53226
Minneapolis Hospital
Minneapolis, Minnesota, 55407
Yale University
New Haven, Connecticut, 06437
Christiana Care Hospital
Newark, Delaware, 19713
Sacred Heart
Pensacola, Florida, 32504
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Heart and Vascular Institue
Pittsburgh, Pennsylvania, 15232
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Maine Medical Center
Portland, Maine, 04102
VA San Diego
San Diego, California, 92161
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
Bay State Hospital
Springfield, Massachusetts, 01199
Scott & White Healthcare System
Temple, Texas, 76508
Tucson Medical Center
Tucson, Arizona, 85712
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010

Other trials in United States

Germany1 site

University of Heidelberg
Heidelberg, Baden-Wurttemberg, D-69120

Other trials in Germany

Netherlands1 site

Rijnstate Hospital
Arnhem, 90

Other trials in Netherlands

United Kingdom1 site

Addenbrooke's Hospital
Cambridge, CB2 0QQ

Other trials in United Kingdom

About this study

Official title: Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Read the detailed description

This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability. Following appropriate government and ethics committee/IRB approval the Nellix® EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study. Enrolled patients will undergo a high resolution, contrast-enhanced computed tomography angiography (CT) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. Follow-up visits will occur at 30 days, 6 months, and annually to 5 years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results.

Conditions: Abdominal Aortic Aneurysm (AAA)
Being tested: Nellix System
Keywords: Infrarenal, Abdominal, Aortic, Aneurysm, AAA, Endologix, EVAS, EndoVascular, Sealing, System
Medical subject headings: Aortic Aneurysm, Abdominal, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nellix SystemDevice
Subjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.

Study groups in NCT01726257
Study group	Role	What they receive
Nellix System	Experimental	Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study. Receives: Device: Nellix System

What is being measured

The primary outcome is the main question the study is designed to answer.

Major Adverse Events at 30 Days
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
Measured: 30 days
Treatment Success at 1 Year
Procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Dec 2022

First posted14 Nov 2012 (estimated)
Study startDec 2013
Primary completionJun 2016
Study completionDec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Abdominal Aortic Aneurysm (AAA)Studies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01726257
Sponsor's protocol ID: CP-0008
Acronym: EVAS1
Status last verified: Feb 2025
First submitted: 19 Oct 2012
Last updated: 28 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K. Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91.
PubMed 22885361
Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15.
PubMed 21497521
Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Hashemi H, Cuff R; Nellix Investigators. Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results. J Vasc Surg. 2020 Sep;72(3):918-930.e2. doi: 10.1016/j.jvs.2019.11.039. Epub 2020 Feb 5.
PubMed 32035772
Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Buckley CJ, Hashemi H, Cuff R; Nellix Investigators. Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial. J Vasc Surg. 2018 Sep;68(3):720-730.e1. doi: 10.1016/j.jvs.2018.01.031. Epub 2018 Mar 31.
PubMed 29609994
Carpenter JP, Cuff R, Buckley C, Healey C, Hussain S, Reijnen MM, Trani J, Bockler D; Nellix Investigators. Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing. J Vasc Surg. 2016 Jan;63(1):23-31.e1. doi: 10.1016/j.jvs.2015.07.096. Epub 2015 Oct 21.
PubMed 26482997

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Abdominal Aortic Aneurysm (AAA) trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study
ClinicalTrials.gov ID: NCT01726257
Acronym / sponsor ID: EVAS1 / CP-0008
Conditions: Abdominal Aortic Aneurysm (AAA)
Keywords: Infrarenal, Abdominal, Aortic, Aneurysm, AAA, Endologix, EVAS, EndoVascular
Study type: Interventional
Recruitment status: Completed
Enrolment: 333 participants (actual)
Lead sponsor: EndologixIndustry (pharma, biotech, devices)
Study start: Dec 2013 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Dec 2022 (actual)
First posted: 14 Nov 2012 (estimated)
Results: Posted 6 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nellix System	Experimental	Device: Nellix SystemNellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female at least 18 years old;
Informed consent understood and signed;
Patient agrees to all follow-up visits;
Have AAA with sac diameter ≥5.0cm, or ≥4.5 cm which has increased by >1.0cm in the past year.
Anatomic eligibility for the Nellix System per the instructions for use:

Key exclusion criteria (13 listed)

Life expectancy <2 years;
Psychiatric or other condition that may interfere with the study;
Participating in enrollment of another clinical study
Known allergy to device any device component;
Coagulopathy or uncontrolled bleeding disorder;

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 SystemSubjects in this study will receive a Nellix Endovascular Sealing System as part of their intervention.	Device	Nellix System

Primary outcome

Major Adverse Events at 30 Days
Time frame: 30 days
Major Adverse Events = all-cause death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, and blood loss >1,000cc
Treatment Success at 1 Year
Time frame: 1 year
Procedural technical success and the absence of aneurysm rupture, conversion to open surgical repair, Type I endoleak at 12 months, Type III endoleak at 12 months, aneurysm enlargement, secondary procedure for resolution of endoleak (Type I or III), limb occlusion, migration, aneurysm sac expansion and/or a device defect.

Results and safety

Results posted to the registry on 6 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pivotal Cohort (ITT)	150	86
Roll-In Cohort	29	8
Continued Access Cohort	154	75

Primary outcome: Major Adverse Events at 30 Days

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Pivotal Cohort n = 150	Roll-In Cohort n = 29	Continued Access Cohort n = 154
Value	4	1	2

Primary outcome: Treatment Success at 1 Year

Time frame: 1 year. Count of participants. Unit: Participants

Measure	Pivotal Cohort (ITT) n = 134	Roll-In Cohort n = 26	Continued Access Cohort n = 109
Value	126	22	94

Adverse events

Time frame: All serious and non-serious events within 30 days, at 6 months, and annually to 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pivotal Cohort (ITT)	26 of 150 (17.3%)	38 of 150 (25.3%)	1 of 150
Roll-In Cohort	5 of 29 (17.2%)	7 of 29 (24.1%)	0 of 29
Continued Access Cohort	37 of 154 (24%)	40 of 154 (26%)	1 of 154

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22885361Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K. Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91.
Background: PubMed 21497521Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK. EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15.
Derived from this study: PubMed 32035772Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Hashemi H, Cuff R; Nellix Investigators. Proper technical procedures improved outcomes in a retrospective analysis of EVAS FORWARD IDE trial 3-year results. J Vasc Surg. 2020 Sep;72(3):918-930.e2. doi: 10.1016/j.jvs.2019.11.039. Epub 2020 Feb 5.
Derived from this study: PubMed 29609994Carpenter JP, Lane JS 3rd, Trani J, Hussain S, Healey C, Buckley CJ, Hashemi H, Cuff R; Nellix Investigators. Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial. J Vasc Surg. 2018 Sep;68(3):720-730.e1. doi: 10.1016/j.jvs.2018.01.031. Epub 2018 Mar 31.
Derived from this study: PubMed 26482997Carpenter JP, Cuff R, Buckley C, Healey C, Hussain S, Reijnen MM, Trani J, Bockler D; Nellix Investigators. Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing. J Vasc Surg. 2016 Jan;63(1):23-31.e1. doi: 10.1016/j.jvs.2015.07.096. Epub 2015 Oct 21.

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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.

Jeffrey Carpenter, MD principal investigator

Cooper Hospital, Camden, NJ

30 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nellix System in people with Abdominal Aortic Aneurysm (AAA), run by Endologix at 30 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 11 inclusion and 13 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Germany, Netherlands, United Kingdom. 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?

Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Major Adverse Events at 30 Days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01726257, which also lists 5 linked publications.

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 28 Feb 2025.