Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts
Recruiting
N/AInterventional Study
Juxtarenal Aortic AneurysmsSuprarenal Aortic AneurysmsType IV Thoracoabdominal Aortic Aneurysms
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Gustavo S Oderich · Other
Who this trial is looking for
This trial is looking for patients with specific types of aortic aneurysms. Participants will receive treatment using a special stent graft and will be monitored for outcomes and quality of life.
Are You a Good Fit for This Trial?
You may be able to join if
I have an aortic aneurysm that is 5.0 cm or larger
I have had an aneurysm that has grown by at least 0.5 cm per year
I have a saccular aneurysm that my doctor thinks is at risk for rupture
You may not be able to join if
I am under 18 years old
I cannot commit to follow-up appointments
I cannot give informed consent
I am pregnant or breastfeeding
I have a life expectancy of less than 2 years
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Eligibility Criteria
General Inclusion Criteria
* A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
* Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥…
General Inclusion Criteria
* A patient may be included in the study if the patient has at least one of the following and is appropriate for treatment with a custom-made Zenith® Fenestrated AAA Endovascular Graft:
* Juxtarenal, suprarenal or type IV thoracoabdominal aortic aneurysm with a diameter ≥ 5.0 cm or 2 times the normal aortic diameter
* Aneurysm with a history of growth ≥ 0.5 cm per year
* Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
General Exclusion Criteria
* Less than 18 years of age
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent by the patient or a legally authorized representative
* Pregnant or breastfeeding
* Life expectancy \< 2-years
* Additional medical restrictions as specified in the Clinical Investigation Plan
* Additional anatomical restrictions as specified in the Clinical Investigation Plan
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