Subjects for this study will have been diagnosed with a bulge or aneurysm in their 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 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 the aneurysm.
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 in place of the aneurysm. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm.
The upper portion of the graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) that allow the graft to be located above the renal arteries without blocking blood flow to them. These small holes or branches are the investigational part of this research study. This is needed when there is not enough healthy aorta below the renal arteries. At least one artery may also be treated with an alignment 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.