CompletedNCT03298477EVAS2Updated May 19, 2026Results posted

EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study

An interventional study of Nellix® System in Abdominal Aortic Aneurysm Without Rupture, sponsored by Endologix. Completed at 27 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Endologix · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 98
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 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.

Conditions studied

Abdominal Aortic Aneurysm Without Rupture

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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):
1. Adequate iliac/femoral access compatible with the required delivery systems (diameter ≥6 mm);
2. Aneurysm blood lumen diameter ≤60mm;
3. Proximal non-aneurysmal aortic neck: length ≥10mm; diameter 18 to 28mm; angle ≤60° to the aneurysm sac;
4. Most caudal renal artery to each hypogastric artery length ≥100mm;
5. Common iliac artery lumen diameter between 9 and 35mm;
6. Distal iliac artery seal zone with length of ≥10mm and diameter range of 9 to 25mm;
7. Ability to preserve at least one hypogastric artery.
8. Ratio of maximum aortic aneurysm diameter to maximum aortic blood lumen diameter \<1.40

Exclusion criteria

EXCLUSION CRITERIA

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;
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).

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 98 participants (actual)

Study arms

Other
Single Arm
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
Device: Nellix® System

Interventions

DeviceNellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System

What researchers measure

Primary outcomes

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
Time frame: 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.
Time frame: 2 year

Secondary outcomes

Conversions, Death and Ruptures
Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,
Time frame: 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).
Time frame: 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).
Time frame: 2 Years
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
Average Sac Diameter size at Visit
Time frame: 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
Time frame: 2 Years
Secondary Interventions
All Secondary interventions reported during the study
Time frame: 2 Years
LABS-RENAL FUNCTION (EGFR)
The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit
Time frame: 2 Years
LABS- RENAL FUNCTION (CREATININE)
Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit
Time frame: 2 Years

Results

Posted Mar 19, 2025

Participant flow

1 Month Follow-Up

Participant flow — 1 Month Follow-Up
Milestone	Single Arm Nellix EndoVascular Aneurysm Sealing System
Started	98
Completed	97
Not completed	1

6 Month Follow-Up

Participant flow — 6 Month Follow-Up
Milestone	Single Arm Nellix EndoVascular Aneurysm Sealing System
Started	97
Completed	93
Not completed	4

1 Year Follow-Up

Participant flow — 1 Year Follow-Up
Milestone	Single Arm Nellix EndoVascular Aneurysm Sealing System
Started	93
Completed	91
Not completed	2

2 Year Follow-Up

Participant flow — 2 Year Follow-Up
Milestone	Single Arm Nellix EndoVascular Aneurysm Sealing System
Started	91
Completed	81
Not completed	10

Outcome measures

PrimarySafety: 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

Time frame:: 30 days
Reported as:: Number · Number of Events

Safety: Major Adverse Events (MAE)
Number of Events	Nellix System
Death	1
Myocardial Infarction	2
Renal Failure	2

PrimaryEffectiveness: 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.

Time frame:: 2 year
Reported as:: Number · percentage of treatment success

Effectiveness: Rate of Treatment Success
percentage of treatment success	Nellix System
Effectiveness: Rate of Treatment Success	92.2

SecondaryConversions, Death and Ruptures

Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,

Time frame:: 2 Years
Reported as:: Number · Number of Events

Conversions, Death and Ruptures
Number of Events	Nellix EndoVascular Aneurysm Sealing System
Conversion	0
Deaths	7
Ruptures	0

SecondaryDevice 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).

Time frame:: 2 Years
Reported as:: Number · Number of Events

Device Integrity
Number of Events	Nellix EndoVascular Aneurysm Sealing System:
Stenosis	5
Stent Occlusion	4
Migration>5mm	1
Migration >10mm	0
Stent Kinking	0
Stent Fracture	0

SecondaryDevice 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).

Time frame:: 2 Years
Reported as:: Count of participants · Participants

Device Performance - Endoleak
Participants	Single Arm Nellix EndoVascular Aneurysm Sealing System
Endoleak Type IA	5
Endoleak Type IB	1
Endoleak Type II	6
Endoleak Type III	0
Endoleak Type IV	0
Endoleak Unknown	1

SecondaryDEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size

Average Sac Diameter size at Visit

Time frame:: 2 years
Reported as:: Mean · mm

DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size
mm	Nellix System
DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size	55.4 ± 5.9

SecondaryDEVICE 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

Time frame:: 2 Years
Reported as:: Number · Number of subjects

DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Changes in Sac Size Since 01 Month
Number of subjects	Nellix System
Decreased >5mm	3
Stable +- 5mm	69
Increased >5mm	4
No Growth	72

SecondarySecondary Interventions

All Secondary interventions reported during the study

Time frame:: 2 Years
Reported as:: Number · Number of Events

Secondary Interventions
Number of Events	Nellix System
Conversion to open repair due to aneurysm expansion	0
Iliac Extension due to aneurysm expansion	1
Iliac Stenting due to renal failure	1
Renal stent due to renal failure	1
Iliac Extension due to Vessel Dissection (Non aortic)	1
Thrombolysis due to Vessel Dissection (Non aortic)	1
Conversion to Open Repair due to endoleak IA	0
Coil Embolization due to Endoleak II	1
Thrombolysis due to Stent Thrombosis	2
Stent relining due to Stent Thrombosis	1
Fem-Fem Bypass due to Stent Thrombosis	1
Conversion to Open Repair due to stent migration	0
Renal stent due to Renal Artery Occlusion	1

SecondaryLABS-RENAL FUNCTION (EGFR)

The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit

Time frame:: 2 Years
Reported as:: Mean · mL/min/1.73 m^2

LABS-RENAL FUNCTION (EGFR)
mL/min/1.73 m^2	Nellix System
LABS-RENAL FUNCTION (EGFR)	66 ± 24

SecondaryLABS- RENAL FUNCTION (CREATININE)

Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit

Time frame:: 2 Years
Reported as:: Mean · mg/dL

LABS- RENAL FUNCTION (CREATININE)
mg/dL	Nellix System
LABS- RENAL FUNCTION (CREATININE)	1.19 ± 0.42

Adverse events

Collected over All Adverse Events data occurring during the study period were collected (i.e. procedure through 5 years follow-up). The data reported here are as of the data cut for 2-year primary endpoint data.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Single Arm Nellix EndoVascular Aneurysm Sealing System	7/98 (7.1%)	49/98 (50%)	22/98 (22.4%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Single Arm Nellix EndoVascular Aneurysm Sealing System
MiscellaneousGeneral disorders	19/98
CardiacCardiac disorders	11/98
PulmonaryRespiratory, thoracic and mediastinal disorders	8/98
RenalRenal and urinary disorders	8/98
Bleeding/AnemiaBlood and lymphatic system disorders	5/98
MalignanciesNeoplasms benign, malignant and unspecified (incl cysts and polyps)	5/98
NeurologicalNervous system disorders	5/98
UrogenitalRenal and urinary disorders	5/98
BowelGastrointestinal disorders	4/98
Nellix DeviceProduct Issues	4/98

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Single Arm Nellix EndoVascular Aneurysm Sealing System
MiscellaneousGeneral disorders	12/98
UrogenitalRenal and urinary disorders	5/98
CardiacCardiac disorders	3/98
RenalRenal and urinary disorders	3/98
MalignanciesNeoplasms benign, malignant and unspecified (incl cysts and polyps)	2/98
VascularVascular disorders	2/98
BowelGastrointestinal disorders	1/98
Nellix DeviceProduct Issues	1/98
NeurologicalNervous system disorders	1/98
Surgical Site WoundSurgical and medical procedures	1/98

Baseline characteristics

The baseline analysis population is 97 subjects. A total of 98 subjects were enrolled, with 97/98 subjects implanted with the Nellix System.

Age, Continuous
Age, Continuous(years)	Single Arm Nellix EndoVascular Aneurysm Sealing System
Mean	73 ± 9

Sex: Female, Male
Sex: Female, Male(Participants)	Single Arm Nellix EndoVascular Aneurysm Sealing System
Female	11
Male	86

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Single Arm Nellix EndoVascular Aneurysm Sealing System
Caucasian	89
Non Caucasian	8

Region of Enrollment
Region of Enrollment(participants)	Single Arm Nellix EndoVascular Aneurysm Sealing System
United States	97

Height
Height(cm)	Single Arm Nellix EndoVascular Aneurysm Sealing System
Mean	177 ± 10

ASA Class (ASA Physical Status Classification System)
ASA Class (ASA Physical Status Classification System)(Participants)	Single Arm Nellix EndoVascular Aneurysm Sealing System
ASA Class 1/2	32
ASA Class 3/4/5	65

SVS Class (Society for Vascular Surgery Classification System) SVS/AAVS comorbidity score
SVS Class (Society for Vascular Surgery Classification System) SVS/AAVS comorbidity score(Participants)	Single Arm Nellix EndoVascular Aneurysm Sealing System
SVS Score: 0/1	93
SVS Score: 2/3/4	4

Study locations

27 sites

Valley Vascular Consultants
Huntsville, Alabama 35801, United States
Regents of the University of California (UCLA)
Los Angeles, California 90095, United States
Veterans Medical Research Foundation
San Diego, California 92161, United States
UC Health-Memorial Hospital
Colorado Springs, Colorado 80909, United States
MedStar Health Research Institute
Washington D.C., District of Columbia 20010, United States
Miami Cardiac & Vascular Institute (MCVI)
Miami, Florida 33176, United States
AdventHealth Orlando
Orlando, Florida 32803, United States
Coastal Vascular & Interventional
Pensacola, Florida 32503, United States
Christie Clinic
Champaign, Illinois 61820, United States
AMITA Health
Elk Grove Village, Illinois 60007, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana 46290, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
McLaren Bay Region
Bay City, Michigan 48708, United States
Midwest Aortic & Vascular Institute
Kansas City, Missouri 64116, United States
The Cooper Health System
Camden, New Jersey 08103, United States
New Mexico Heart Institute
Albuquerque, New Mexico 87102, United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Northeast Ohio Vascular Assoc (NEOVA)
Willoughby, Ohio 44095, United States
OU College of Medicine
Tulsa, Oklahoma 74135, United States
Providence St. Vincent Medical Center
Portland, Oregon 97213, United States
Palmetto Health- University of South Carolina
Columbia, South Carolina 29203, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee 37660, United States
Cardiovascular Surgery Clinic
Memphis, Tennessee 38120, United States
Inova Research Center
Falls Church, Virginia 22042, United States
Providence Sacred Heart Medical Center
Spokane, Washington 99204, United States
Aspirus Research Institute
Wausau, Wisconsin 54401, United States

References and documents

Study documents

Protocol and statistical analysis plan · Mar 30, 2020
Informed consent form · Aug 7, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03298477
Lead sponsor: Endologix
Responsible party: Sponsor
First posted: Oct 2, 2017
Start date: Dec 1, 2017
Primary completion: Jun 7, 2022
Completion: Aug 16, 2025
Results posted: Mar 19, 2025
Last update: May 19, 2026

Study contacts

Jeffrey Carpenter, MD

principal investigator · Cooper Hospital

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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