An interventional study of Custom-made Zenith® Fenestrated AAA Endovascular Graft: in Juxtarenal Aortic Aneurysms, Suprarenal Aortic Aneurysms and Type IV Thoracoabdominal Aortic Aneurysms, sponsored by Gustavo S Oderich. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Gustavo S Oderich · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate clinical outcomes and quality of life measures in treated by endovascular aortic repair of juxtarenal, suprarenal, and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft.
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 200 is above the median of 62 across 101 interventional studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →Gustavo S Oderich is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
General Inclusion Criteria
General 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.
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.
The study will include patients treated by endovascular aortic repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms using custom-made Cook Zenith® Fenestrated AAA Endovascular Graft. The graft includes combinations of scallops, holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. Other names: Endovascular stent Stent-graft
Device: Custom-made Zenith® Fenestrated AAA Endovascular Graft:
The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.
Also known as: Endovascular stent, Stent-graft
Number of subjects who have die at 30 days post treatment
Deaths 30 days after treatment
Time frame: 30 days post treatment]
Number of subjects who experience a Major Adverse Event at 30 days post treatment
A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.
Time frame: 30 days post treatment
Subject Scores on Short Form-36 (SF-36) Quality of Life Questionnaire
Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Time frame: baseline, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years.
Number of Subjects Who Achieve Treatment Success
Treatment success is defined by a composite end-point, which includes all the following criteria described below: * Technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved. * Freedom from type I or III endoleak. * Freedom from stent-graft migration. * Freedom from aneurysm enlargement \>5mm * Freedom from aneurysm rupture or conversion to open repair.
Time frame: 12 months
Not enrolling at this site.
Plan to share: No
Ran from Aug 2013 to primary completion in Mar 2025, 139 months.
Of 44 interventional studies with no phase under Aortic Aneurysm, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 70. This study's 139 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Gustavo S Oderich