The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and
customized physician-specified stent-graft with a combination of fenestrations and/or
branches to repair aortic aneurysm.
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.
Subjects will have been diagnosed with a bulge or aneurysm in their aortic arch and or
abdominal aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most
of the lower body including major organs and the legs.
The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a
tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft
open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of
blood with a high risk of death and other serious complications. To avoid this risk the
aneurysm will be repaired by putting a graft inside the aneurysm. The graft will be inserted
through arteries in the groin (called endovascular repair). This procedure uses catheters
that go inside the blood vessel to place a stent-graft above and below the aneurysm.
The graft includes 1 to 5 small 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 have a stent (small tubular stainless steel structures) to
help keep the arteries open and aligned with the fenestrations or branches. The Zenith
t-Branch and physician-specified fenestrated and branched endovascular graft will be referred
to as the Zenith Fenestrated-Branched System.
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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