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
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.
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.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 98 is above the median of 66 across 228 interventional studies indexed under Aortic Aneurysm, Abdominal.
Browse Aortic Aneurysm, Abdominal studies →Endologix is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 9 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A patient who meets all of the following criteria potentially may be included in the study:
Anatomically eligible for the Nellix System (per Instructions For Use):
EXCLUSION CRITERIA
A patient who meets none of the following criteria potentially may be included in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single Arm Safety and Effectiveness Confirmatory Study of EVAS using the Nellix® System
Device: Nellix® System
Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
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
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
| Milestone | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Started | 98 |
| Completed | 97 |
| Not completed | 1 |
| Milestone | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Started | 97 |
| Completed | 93 |
| Not completed | 4 |
| Milestone | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Started | 93 |
| Completed | 91 |
| Not completed | 2 |
| Milestone | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Started | 91 |
| Completed | 81 |
| Not completed | 10 |
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
| Number of Events | Nellix System |
|---|---|
| Death | 1 |
| Myocardial Infarction | 2 |
| Renal Failure | 2 |
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.
| percentage of treatment success | Nellix System |
|---|---|
| Effectiveness: Rate of Treatment Success | 92.2 |
Number of Deaths, Conversion and ruptures through the data cut of the July 7, 2023,
| Number of Events | Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Conversion | 0 |
| Deaths | 7 |
| Ruptures | 0 |
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).
| 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 |
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).
| 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 |
Average Sac Diameter size at Visit
| mm | Nellix System |
|---|---|
| DEVICE PERFORMANCE-ANEURYSM SAC DIAMETER- Avg Size | 55.4 ± 5.9 |
Number of subjects that had changes in the Sac Diameter size since the 1 month follow-up visit
| Number of subjects | Nellix System |
|---|---|
| Decreased >5mm | 3 |
| Stable +- 5mm | 69 |
| Increased >5mm | 4 |
| No Growth | 72 |
All Secondary interventions reported during the study
| 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 |
The outcome demonstrates the protocol specified laboratory values (collected as eGFR) captured at each follow-up visit
| mL/min/1.73 m^2 | Nellix System |
|---|---|
| LABS-RENAL FUNCTION (EGFR) | 66 ± 24 |
Labs- Renal Function demonstrates the protocol specified laboratory values (Collected as creatinine) captured at each follow-up visit
| mg/dL | Nellix System |
|---|---|
| LABS- RENAL FUNCTION (CREATININE) | 1.19 ± 0.42 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm Nellix EndoVascular Aneurysm Sealing System | 7/98 (7.1%) | 49/98 (50%) | 22/98 (22.4%) |
| 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 |
| 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 |
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(years) | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Mean | 73 ± 9 |
| Sex: Female, Male(Participants) | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Female | 11 |
| Male | 86 |
| Race/Ethnicity, Customized(Participants) | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Caucasian | 89 |
| Non Caucasian | 8 |
| Region of Enrollment(participants) | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| United States | 97 |
| Height(cm) | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| Mean | 177 ± 10 |
| 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(Participants) | Single Arm Nellix EndoVascular Aneurysm Sealing System |
|---|---|
| SVS Score: 0/1 | 93 |
| SVS Score: 2/3/4 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2017 to primary completion in Jun 2022, 54 months.
Results were first posted in Mar 2025, 2 years 9 months after primary completion.
Of 43 industry-sponsored interventional studies with no phase under Aortic Aneurysm, Abdominal, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 65. This study's 54 months is above that.
Counting every sponsor, half of 94 studies reached it within 43 months; a quarter within 23 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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