Complex Abdominal Aortic Aneurysm Repair With Fenestrated Stent Grafts

  • STATUS
    Recruiting
  • End date
    May 19, 2030
  • participants needed
    200
  • sponsor
    Gustavo Oderich
Updated on 24 January 2022

Summary

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.

Description

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.

Details
Condition Juxtarenal Aortic Aneurysms, Suprarenal Aortic Aneurysms, Type IV Thoracoabdominal Aortic Aneurysms
Treatment Custom-made Zenith® Fenestrated AAA Endovascular Graft:
Clinical Study IdentifierNCT01937949
SponsorGustavo Oderich
Last Modified on24 January 2022

Eligibility

Yes No Not Sure

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

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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