Visceral (Kidney and Abdominal Organ) Function After Fenestrated and Branched Endovascular Aneurysm Repair (FEVAR/BEVAR) of Thoracoabdominal Aortic Aneurysms

This is an interventional other trial for Aortic Aneurysm, Abdominal focused on measuring Aortic Aneurysm, abdominal Read More

Inclusion Criteria:

Patients may be included in the study if the patient has at least one of the following and has aortic anatomy appropriate for treatment with the Zenith® p-Branch™, Zenith® t-Branch, or Physician Specified TAAA Endovascular Graft (Custom Manufactured Devices).

1. Aortic Aneurysm Diameter

   1. TAAA (Type I - IV) (including pararenal subtypes) with orthogonal aortic diameter greater than or equal to 5 cm or
   2. greater than two times the normal aortic diameter
2. Rapid aortic enlargement (> than or equal to 5mm in 1 year)
3. Presence of a saccular aneurysm at risk for rupture based on investigators evaluation
4. Iliac artery aneurysm ˃2.2 cm may be treated with the Zenith® Branch Endovascular Graft-Iliac Bifurcation when the iliac artery aneurysm is associated with the qualifying thoracoabdominal aneurysm treated in this study

Exclusion Criteria:

General Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

1. Less than 18 years of age
2. Unwilling to comply with the follow-up schedule
3. Inability or refusal to give informed consent

Medical Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

1. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold
2. History of anaphylactic reaction to contrast material that cannot be adequately premedicated
3. Leaking, ruptured aneurysm associated with hypotension
4. Uncorrectable coagulopathy

Anatomical Exclusion Criteria

Patients must be excluded from the study if any of the following conditions are true:

1. Inadequate femoral/iliac access compatible with the required delivery systems;

2. Does not have a non-aneurysmal aortic segment proximal to the aneurysm with:

   1. A length of at least 4 mm, i.e. at least 4 mm circumferential wall contact around the limits of scallop
   2. A diameter measured outer wall to outer wall of no greater than 31mm and no less than 21 mm;
   3. An angle less than 60 degrees relative to the centerline of the aneurysm;
   4. An angle less than 45 degrees relative to the supraceliac aorta.

3. Does not have visceral vessel anatomy compatible with Zenith® p-Branch™, specifically:

   1. Renal vessel origins as measured relative to the superior mesenteric artery (SMA) compatible with the renal fenestration, i.e. Both renal vessel origins within 7.5mm of the corresponding renal fenestrations;
   2. Celiac vessel origin as measured relative to the superior mesenteric artery (SMA) compatible with the celiac scallop.
4. A proximal seal site with unsuitable thrombus/atheroma

5. Does not have iliac artery fixation sites and anatomy consistent with:

   1. Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) <8.0 mm (prior to deployment)
   2. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site
   3. Iliac artery distal fixation site <10 mm in length

   4. Inability to preserve at least one hypogastric artery

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