An interventional study of The Nellix® EndoVascular Aneurysm Sealing System in Abdominal Aortic Aneurysms, sponsored by Endologix. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by Endologix · Not applicable, Interventional, and Treatment
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.
This is a multicenter, multi-country prospective, single-arm, non-randomized clinical trial. The comparative control arm is a combination of patient data drawn from the abdominal aortic aneurysms (AAA) open surgical control arms of four commercially approved AAA devices as part of the Society of Vascular Surgeons. Patients enrolled in this study will be pre-screened and have a diagnosis of an infrarenal AAA with or without the need for treatment of iliac artery aneurysm, are candidates for endovascular repair, and meet the eligibility criteria. Patients enrolled in the study will participate in follow-up visits 31 days, 6 months and at 1 year following the index procedure. At the follow-up visits there will be a clinical assessment, blood collection, and abdominal CT imaging of the patient.
467 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 99 are open to participants now.
This study's enrollment of 69 is close to 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.
Is a candidate for endovascular repair of an infrarenal aortic aneurysm with or without an iliac aneurysm with at least one of the following;
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.
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 drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Nellix® EndoVascular Aneurysm Sealing System
Device: The Nellix® EndoVascular Aneurysm Sealing System
Safety- Number of Major Adverse Events
The primary safety endpoint is defined as the incidence of Major Adverse Events (MAE) through 30 days after the index procedure.
Time frame: 30 day
Device Performance
The primary performance endpoint is technical success defined as successful delivery and deployment of the device and freedom from open surgical conversion at 30 days.
Time frame: 30 days
All Cause Mortality
Any death occurring during the study period, regardless of cause
Time frame: 12 months
The record gives a start of Dec 2008, a primary completion of Dec 2017 and a completion of Dec 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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