An observational study in Abdominal Aortic Aneurysm, sponsored by Endologix. Completed at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by Endologix · Observational
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)
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 48 is below the median of 165 across 217 observational 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.
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
Device: Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
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.
Also known as: Nellix EVAS FORWARD 2
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 5 years
Number of subjects with Clinically significant migration
The number of patients with clinically significant migration will be summarized descriptively.
Time frame: 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.
Time frame: 5 years
Number of incidence with Secondary endovascular procedures
The overall secondary procedure incidence and the individual component incidence will be provided.
Time frame: 5 years
Number of subjects with incidence of device patency and integrity
Device patency and integrity will be measured by the number and proportion of patients at 30 days, 6 months, and 1 year to 5 years including Stent Kinking, Lumen Occlusion, and Stent Fracture.
Time frame: 5 years
Number of incidence with Distal Complications
The number of incidence of distal thrombosis, embolization and iliac stenosis will be summarized.
Time frame: 5 years
Ran from Nov 2016 to primary completion in Apr 2023, 77 months.
Of 91 observational studies under Aortic Aneurysm, Abdominal, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 83. This study's 77 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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