Abdominal Aortic Aneurysm Without RuptureEVAS2NCT03298477
EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
A study testing Nellix® System in people with Abdominal Aortic Aneurysm Without Rupture, run by Endologix at 27 sites in United States.
Trial summary
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure 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 Without Rupture
- 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
- 98 participants
- Where
- 27 sitesUnited States
- Study dates
- 1 Dec 2017to 16 Aug 2025
- 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
- A patient who meets all of the following criteria potentially may be included in the study:
- Male or female at least 18 years old;
- Informed consent form understood and signed
- Patient agrees to all follow-up visits;
- Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
- Anatomically eligible for the Nellix System (per Instructions For Use):
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- Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
- Aneurysm blood lumen diameter ≤60mm;
- Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
- Most caudal renal artery to each hypogastric artery length ≥100mm;
- Common iliac artery lumen diameter between 9 and 35mm;
- Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
- Ability to preserve at least one hypogastric artery.
- Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter <1.40
Who cannot join
- A patient who meets none of the following criteria potentially may be included in the study:
- Life expectancy <2 years as judged by the Investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in another clinical study;
- Known allergy or contraindication to any device material;
- Coagulopathy or uncontrolled bleeding disorder;
Show all 14Show fewer
- Ruptured, leaking or mycotic aneurysm;
- Serum creatinine (S-Cr) level >2.0 mg/dL;
- CVA or MI within three months of enrollment/treatment;
- Aneurysmal disease of the descending thoracic aorta;
- Clinically significant mural thrombus within the proximal landing zone (minimum 10mm) of the infrarenal non-aneurysmal neck (>5mm thickness over >50% circumference);
- Connective tissue diseases (e.g., Marfan Syndrome);
- Unsuitable vascular anatomy that may interfere with device introduction or deployment;
- Pregnant (female of childbearing potential only).
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
McLaren Bay Region
Bay City, Michigan, 48708
Massachusetts General Hospital
Boston, Massachusetts, 02114
The Cooper Health System
Camden, New Jersey, 08103
Christie Clinic
Champaign, Illinois, 61820
Cleveland Clinic
Cleveland, Ohio, 44195
UC Health-Memorial Hospital
Colorado Springs, Colorado, 80909
Palmetto Health- University of South Carolina
Columbia, South Carolina, 29203
AMITA Health
Elk Grove Village, Illinois, 60007
Inova Research Center
Falls Church, Virginia, 22042
Valley Vascular Consultants
Huntsville, Alabama, 35801
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
Midwest Aortic & Vascular Institute
Kansas City, Missouri, 64116
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Regents of the University of California (UCLA)
Los Angeles, California, 90095
Cardiovascular Surgery Clinic
Memphis, Tennessee, 38120
Miami Cardiac & Vascular Institute (MCVI)
Miami, Florida, 33176
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
AdventHealth Orlando
Orlando, Florida, 32803
Coastal Vascular & Interventional
Pensacola, Florida, 32503
Providence St. Vincent Medical Center
Portland, Oregon, 97213
Veterans Medical Research Foundation
San Diego, California, 92161
Providence Sacred Heart Medical Center
Spokane, Washington, 99204
OU College of Medicine
Tulsa, Oklahoma, 74135
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Aspirus Research Institute
Wausau, Wisconsin, 54401
Northeast Ohio Vascular Assoc (NEOVA)
Willoughby, Ohio, 44095
About this study
Official title: Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
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 safety and effectiveness outcomes. 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.
- Being tested
- Nellix® System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nellix® SystemDevice
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System Receives: Device: Nellix® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Major Adverse Events (MAE)
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc
Measured: 30 days
Effectiveness: Rate of Treatment Success
The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows:
It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; > 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.
Measured: 2 year
Secondary outcomes (8)
Conversions, Death and Ruptures
Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,
Measured: 2 Years
Device Integrity
Device Integrity is defined as the absence of device fracture, stenosis, kink, occlusion, or migration >5mm. All incidences of stent occlusion (100% device lumen obstruction) are also captured as stent stenosis (<100% device lumen obstruction).
Measured: 2 Years
Device Performance - Endoleak
Demonstrates device performance as indicated by the incidence of Endoleaks through study follow-up. Endoleak is determined by the CoreLab based on imaging completed. Endoleak is defined as clear evidence of contrast outside of one or both EndoBags which communicates with the aneurysm sac originating proximally at the infrarenal segment (Type IA), distally (Type IB); between components, if an extender is used (Type III); trans-device (Type IV); or from a patent collateral vessel (Type II: e.g., lumbar artery; inferior mesenteric artery).
Measured: 2 Years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
Average Sac Diameter size at Visit
Measured: 2 years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month
Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit
Measured: 2 Years
Secondary Interventions
All Secondary interventions reported during the study
Measured: 2 Years
LABS-RENAL FUNCTION (EGFR)
The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit
Measured: 2 Years
LABS- RENAL FUNCTION (CREATININE)
Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start1 Dec 2017
- Primary completion7 Jun 2022
- Study completion16 Aug 2025
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.
- Other trials for Abdominal Aortic Aneurysm Without RuptureStudies 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
- Model description
- Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Carpenter, MD, Principal investigator, Cooper Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298477
- Sponsor's protocol ID
- CP-0008 EVAS2 IDE
- Acronym
- EVAS2
- Status last verified
- Apr 2026
- First submitted
- 27 Sep 2017
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System IDE Study (EVAS 2 Confirmatory IDE Study)
- ClinicalTrials.gov ID
- NCT03298477
- Acronym / sponsor ID
- EVAS2 / CP-0008 EVAS2 IDE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
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 safety and effectiveness outcomes. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System. Sites have been chosen with a suitable research infrastructure and physician experience in endovascular aneurysm repair to ensure adequate enrollment. Subjects will be followed procedurally to discharge, at 30 days (primary safety endpoint), six months, one year (primary effectiveness endpoint) and annually thereafter to five years (total follow-up commitment).
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Nellix® SystemSingle Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A patient who meets all of the following criteria potentially may be included in the study:
- Male or female at least 18 years old;
- Informed consent form understood and signed
- Patient agrees to all follow-up visits;
- Abdominal aortic aneurysm with sac diameter ≥5.0cm, or ≥4.5cm which has increased by ≥0.5cm within the last 6 months, or or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. No AAA <4 cm will be included.
Key exclusion criteria (14 listed)
- A patient who meets none of the following criteria potentially may be included in the study:
- Life expectancy <2 years as judged by the Investigator;
- Psychiatric or other condition that may interfere with the study;
- Participating in another clinical study;
- Known allergy or contraindication to any device material;
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® SystemEndovascular Abdominal Aortic Aneurysm Repair using the Nellix® System | Device | Single Arm |
Primary outcome
Safety: Major Adverse Events (MAE)
Time frame: 30 days
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) at 30 days, defined as the composite of the following All-Cause Mortality; Bowel Ischemia; Myocardial Infarction; Paraplegia; Renal Failure; Respiratory Failure; Stroke; Procedural Blood Loss ≥1,000cc
Effectiveness: Rate of Treatment Success
Time frame: 2 year
The primary effectiveness endpoint is defined as the rate of Treatment Success at year 2. Treatment Success is a composite of outcomes clinically relevant to the endovascular repair of infrarenal AAA as follows: It is defined as procedural technical success and absence of Abdominal aortic aneurysm rupture; Conversion to open surgical repair; Endoleak Type I or III at year 2; Clinically significant migration; > 5mm aneurysm sac enlargement of the maximal diameter as measured by the difference from the 30-Day CT time point; or Secondary endovascular procedure up to year 2 for resolution of Endoleak (Type I or Type III), Device obstruction or occlusion, Device migration, Abdominal aneurysm sac expansion, Device defect.
8 secondary outcomes
Conversions, Death and Ruptures
Time frame: 2 Years
Device Integrity
Time frame: 2 Years
Device Performance - Endoleak
Time frame: 2 Years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
Time frame: 2 years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month
Time frame: 2 Years
Secondary Interventions
Time frame: 2 Years
LABS-RENAL FUNCTION (EGFR)
Time frame: 2 Years
LABS- RENAL FUNCTION (CREATININE)
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
27 sites in 1 country: 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 Without Rupture, run by Endologix at 27 sites in United States.
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 14 inclusion and 14 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 19 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 27 sites in United States. 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 19 Mar 2025). 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?
Safety: Major Adverse Events (MAE) (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?
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 19 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.