Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

Inclusion Criteria:

Subject must have one of the following:

1. Degenerative, atherosclerotic thoracoabdominal aortic aneurysm (fusiform or saccular): ≥55mm in diameter or
2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year.
3. Penetrating ulcers: ≥20mm in depth or
4. Chronic type B aortic dissections: ≥55mm total aortic diameter or
5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size

Exclusion Criteria:

1. Life-expectancy less than 12 months
2. Refusal to receive blood products
3. Age <18 years
4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
5. Unwilling to comply with the follow-up schedule
6. Inability or refusal to give informed consent

Medical Exclusion Criteria

1. Uncontrolled systemic infection
2. Untreatable malignancy
3. MI or stroke in last 90 days
4. Unstable/Ruptured aneurysm
5. Uncontrollable anaphylaxis to iodinated contrast
6. Known allergy(ies) to device materials
7. History of chronic abdominal pain
8. Coagulopathy or any bleeding disorder
9. Contraindication to general anesthesia

Anatomic Exclusion Criteria

1. Any pathology of mycotic origin
2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
3. Extensive thrombus or calcifications in the aortic arch
4. Excessive tortuosity precluding safe passage of the Zenith® t-Branch or its components
5. Inability to insert the Zenith® t-Branch device through iliofemoral approach
6. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm
7. Proximal landing zone length <25mm to allow secure fixation and seal
8. Proximal landing zone diameter of <24mm or >38mm
9. Distal landing zone length <25mm in the abdominal aorta or <20mm in the iliac arteries
10. Distal landing zone diameter of <24mm or >30mm in the abdominal aorta, or <7mm or >20mm in the iliac arteries